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  5. Hans Bakery Inc. d/b/a Andersen’s Bakery - 706794 - 07/29/2025
  1. Warning Letters

WARNING LETTER

Hans Bakery Inc. d/b/a Andersen’s Bakery MARCS-CMS 706794 —

Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Siau Liang Kao
Recipient Title
CEO and Co-Owner
Hans Bakery Inc. d/b/a Andersen’s Bakery

30703 San Clemente Street
Hayward, CA 94544
United States

(b)(6)
Issuing Office:
Human Foods Program

United States

July 29, 2025

WARNING LETTER

Re: CMS # 706794

Dear Mr. Kao:

The United States Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility, located at 30703 San Clemente Street, Hayward, CA, from October 15 to November 4, 2024. The inspection revealed significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). In addition, during the inspection, FDA collected filth samples from various areas within your production facility, and the analytical results revealed rodent and insect filth present throughout your facility.

Based on FDA’s inspectional findings, we determined that your RTE bakery and dessert products and RTE vacuum packaged tuna salad are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, B, C, D, E, F, and G of Part 117) is prohibited by Section 301(uu) of the Act [21 USC § 331(uu)]. Furthermore, in accordance with 21 CFR § 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)]. A label review was also conducted on your RTE vacuum packaged tuna salad and your saffron raisin twist products which found violations of Food Labeling, Title 21, Code of Federal Regulations (CFR), Part 101 (21 CFR Part 101) which causes the product to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].

You may find the Act and further information about FDA’s regulations through links in FDA’s home page at http://www.fda.gov.

At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations, listing the violations found at your facility. FDA received your emailed written response to the FDA-483, Inspectional Observations, dated November 22, 2024, describing corrective actions taken and planned by your firm. You provided documentation including but not limited to a Food Safety Plan, procedures, record templates, employee training presentation, and photographs. After reviewing the inspectional findings and your firm’s response, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your response below.

Your significant violations were as follows:

Seafood HACCP (21 CFR Part 123)

1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written Seafood HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR § 123.6(a) and (b). However, your firm does not have a Seafood HACCP plan for Ready to Eat (RTE) refrigerated vacuum packaged tuna salad products to control the food safety hazards of scombrotoxin/ histamine formation, bacterial pathogen growth and toxin formation, including Clostridium botulinum (C. botulinum) growth and toxin formation associated with your reduced oxygen packaged (ROP) finished products, and undeclared major food allergens. Our investigator observed the following lack of controls during the inspection:

a. On October 18, 2024, you prepared and hand-packaged your tuna salad product in an ambient production room which measured at (b)(4)°F with an FDA-issued handheld thermometer. The manufacturing and packaging processes were performed from approximately (b)(4) am to (b)(4) am. The finished vacuum packaged RTE tuna salad product was placed in “(b)(4) Walking Cooler” at (b)(4)am in which the cooler temperature was measured as (b)(4)°F with the FDA handheld thermometer. The packaged tuna salad product was removed from the cooler for approximately (b)(4) to stage it on carts for delivery the following day. The carts were placed in “(b)(4) Walking Cooler” in which the temperature was measured as (b)(4)°F with the FDA thermometer. Finished vacuum packaged RTE tuna salad products are stored in the “(b)(4) Walking Cooler” approximately (b)(4) hours and (b)(4) minutes before they are removed for loading and distribution operations the following day. Your tuna salad product is removed from “(b)(4) Walking Cooler” and staged for approximately (b)(4) hour before loading into unrefrigerated trucks. Delivery of your RTE vacuum packaged tuna salad product is from (b)(4) am through (b)(4) am. You did not monitor the temperature of the “(b)(4) Walking Cooler” and/or the temperature of the in-process tuna salad and finished vacuum packaged RTE tuna salad product to ensure it had cooled to and is held at appropriate temperatures to prevent histamine formation and bacterial pathogen growth and toxin formation, including C. botulinum.

b. Your tuna salad product is not labeled with a statement of identity, an ingredient statement or allergen statement. The tuna salad product contains the allergens of egg from mayonnaise and fish (tuna).

Your written response, dated November 22, 2024, stated you developed a HACCP plan titled “(b)(4)”. HACCP plans must include all the criteria defined in 21 CFR § 123.6(c). Furthermore, histamine, bacterial pathogen growth/toxin formation due to time/temperature abuse including C. botulinum growth and toxin formation and the tuna allergen were not identified as potential hazards in your food safety plan. Thus, you do not have a written Seafood HACCP plan that includes critical control points (CCP) to ensure that the finished RTE refrigerated vacuum packaged tuna salad products are adequately processed, vacuum packed, or labeled by your firm.

In terms of the corrections you made to your tuna salad manufacturing process to control the potential hazards of bacterial pathogen growth and toxin formation including C. botulinum and histamine, you explained you began monitoring the temperature of (b)(4) walking cooler with a thermometer and provided an image of a dial thermometer located on a wall to demonstrate your current holding temperature. Further, you stated you are maintaining a daily temperature log and provided a “(b)(4)” log template, and the “(b)(4)” states under “(b)(4)” that you have continuous temperature recording via your computerized HVAC system. However, supporting documentation was not provided in your response to demonstrate you are monitoring and recording your cooler’s temperatures. Further, FDA recommends that your refrigerated storage temperatures are monitored with a continuous time and temperature recorder. You also stated you began monitoring product temperature at (b)(4) and provided photographs demonstrating how you measure product temperature at each of these steps. However, you did not define the temperature critical limits/parameters you are monitoring.

When conducting your hazard analysis for your tuna salad process, from receipt of all ingredients through shipment of the finished product, you should consider any cumulative exposure of the product at times and temperatures to identify if the food safety hazards of histamine and bacterial pathogen growth/toxin formation including C. botulinum due to time/temperature abuse are reasonably likely to occur in the absence of controls, such as time and temperature or product formulation. Histamine and bacterial pathogens (e.g. C. botulinum, Listeria monocytogenes, Staphylococcus aureus, Salmonella) may have differing safety recommendations for refrigerated and non-refrigerated temperatures; therefore, the most stringent cumulative time or exposure temperature should be selected to ensure control of the hazards most likely to occur at a particular processing step and subsequently control the other hazards with less stringent control needs.

Processing steps where time and temperature controls are necessary to prevent pathogen growth/toxin formation and histamine formation should be identified as critical control points (CCPs) in your HACCP plan. Any processing steps where you implement product formulation controls to provide a secondary barrier for C. botulinum for the ready-to-eat refrigerated vacuum packaged tuna salad should be included as a CCP and supported with a validation study that identifies the critical processing factors and critical limits. When a secondary barrier is in place for C. botulinum, such as pH of 5.0 or less, water phase salt of 5% or less, or a water activity of 0.97 or less, the products may be safely refrigerated at 40°F. If no secondary barrier is in place, then products should be refrigerated at 38°F and time-temperature integrators affixed to each individual package. See Chapter 13 of the Fish and Fisheries Products and Hazards and Controls Guidance (Guide) for more information and strategies to control C. botulinum growth and toxin formation, Chapter 12 for bacterial pathogen growth and toxin formation (other than C. botulinum), and Chapter 7 for scombrotoxin/histamine formation.

In terms of allergens, you stated you are now labeling the tuna salad product and provided a photograph to show it is labeled as “TUNA SALAD”; however, your current label does not identify all allergens incorporated into the finished product, i.e. fish (tuna) and egg. Your HACCP plan should include a critical control point which ensures that all allergenic ingredients are declared on the finished product labels. See Chapter 19 of the Guide for more information on allergens and adequate allergen labeling

2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR § 123.11(b). However, your firm did not monitor safety of water; conditions and cleanliness of food contact surfaces; prevention of cross contamination; proper labeling, storage and use of toxic compounds; and employee health to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 117 Subpart B, as evidenced by the following observed on October 18, 2024, during manufacturing operations of RTE vacuum packaged tuna salad:

a. An employee entered through the exterior back door near the firm’s dry ingredient storage room pushing a (b)(4)-gallon trash bin with gloved hands. Upon entering the production room, the employee did not change gloves and wash and sanitize their hands before directly handling ingredients such as cucumbers, onions, celery, and cans of tuna used in the manufacturing of the tuna salad. 

b. An employee dropped cling wrap on the production room floor and then picked it up with gloved hands. The employee did not change gloves and did not wash and sanitize their hands before directly handling cucumbers and celery used in the manufacturing of tuna salad.

c. An employee sneezed directly into a (b)(4)-gallon stainless-steel bowl of tuna salad. The employee then wiped their nose with a gloved hand and proceeded to directly touch the tuna salad. The employee did not change gloves and did not wash and sanitize their hands.

d. Chicken salad was mixed in the (b)(4) stand-up mixer prior to the preparation of tuna salad. The mixer had apparent food residue from chicken salad on the inside and underside of the mixer where the metal flat beater attachment attaches. The residue dripped from the underside of the mixer into the (b)(4)-gallon stainless-steel mixing bowl containing tuna salad ingredients. The metal flat beater also appeared to have apparent chicken salad food residue on it.

e. An employee wiped down a cutting board and a single blade knife with a white cloth submerged in unidentified liquid in a bucket labeled as Pastry Glaze. The cutting board and knife were then used to dice cucumber, onions, and celery which were ingredients of the tuna salad. Your Plant Manager identified the liquid as sanitizer from the detergent/sanitizer wall unit which does not get serviced. An FDA-issued chlorine test strip measured the sanitizer strength at 0 ppm.

f. An employee rinsed a stainless-steel colander used to drain cans of tuna with a hose that had apparent mold and unidentified filth inside it. The hose was connected to a detergent/sanitizer wall unit that did not have a back-flow prevention device.

Your written response dated November 22, 2024 explained you provided your employees training in Good Manufacturing Practices (GMPs) including hand-washing in response to the employee practices observed during the inspection. Further, you provided your GMP Program 2024, a GMP Training Presentation, and Training Records dated November 11-14, 2024. We acknowledge your written GMP Program and training presentation defined when and how to wash hands and change gloves. Effectiveness of employee training will be evaluated during the next inspection.

In response to food debris observed on the (b)(4) mixer and flat beater attachment, you explained and provided photographs to demonstrate you purchased a new mixing bowl and flat beater attachment and labeled it for “TUNA USE ONLY”. We acknowledge having a dedicated mixing bowl and flat beater attachment is appropriate to prevent tuna allergen cross contact into your other products that do not contain tuna; however, you did not describe how you will ensure that this mixing bowl and flat beater attachment will be dedicated to tuna use only. Further, you did not address if additional steps were taken to address the (b)(4) mixer itself.

You explained you purchased and provided photographs showing new color-coded buckets labeled as “Sanitizer” and “Multi-Purpose” to hold your cleaning chemicals. In addition, you explained you retrained employees on when and how to correctly make the sanitizer solution to sanitize your equipment. You provided a photograph of a test strip resting on a sanitizer bucket in which you stated it measured (b)(4) ppm. You did not provide documentation to demonstrate you are measuring your sanitizer solution daily in that the record provided was a blank template. In addition, you provided the Food Technology Fact Sheet for chlorine bleach that references 21 CFR Part 178 in which residual chlorine on food contact surfaces may not exceed 200ppm. If higher concentrations are used, “the surface must be rinsed with potable water after sanitizing.” However, your 2024 GMP Program states under “(b)(4).

3. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR § 123.11(b), to comply with 21 CFR § 123.11(c). However, your firm did not maintain sanitation monitoring records for safety of water; conditions and cleanliness of food contact surfaces; prevention of cross contamination; maintenance of handwashing, hand-sanitizing and toilet facilities; protection from adulterants; proper labeling, storage, and use of toxic compounds; employee health conditions and exclusion of pests required for the processing of RTE, refrigerated vacuum packaged tuna salad products.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)

1. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR § 117.126(a)(2). Your food safety plan must also include the following:

1) The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
2) The written preventive controls, as required by 21 CFR § 117.135(b);
3) The written supply-chain program, as required by Subpart G;
4) The written recall plan, as required by 21 CFR § 117.139(a);
5) The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
6) The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
7) The written verification procedures, as required by 21 CFR § 117.165(b).

Your facility manufactures a variety of ready-to-eat (RTE) bakery products and desserts, including but not limited to RTE mango roll cake and RTE saffron raisin twists. However, you did not have a food safety plan with any of the required elements for any of your bakery and dessert products manufactured by your facility. For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of bakery and dessert product manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control (see 21 CFR § 117.130(a)). Also, you did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under Section 402 of the Act or misbranded under Section 403(w) of the Act (see 21 CFR § 117.135(a)(1)). Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135(c)). Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140). Specifically:

a. You did not identify and evaluate food allergens as a known or reasonably foreseeable hazard to determine whether food allergens are a hazard requiring a preventive control, as required under 21 CFR § 117.130(a)(1). Your facility manufactures various bakery and non-bakery products that contain allergens (such as wheat, soy, eggs, milk, tree nuts (e.g. walnuts, pistachios, almonds), and fish (e.g. tuna)). Additionally, products containing different allergen profiles are processed on shared food-contact surfaces (such as bowls and paddles), shared equipment and utensils, on the same production day and with the same employees. Allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be stated are included on the label (see 21 CFR § 117.135(c)(2)(i) and (ii)).

i. You did not have appropriate controls in place to prevent undeclared food allergens (see 21 CFR § 117.135(c)(2)(ii)). During the inspection, our investigator observed:
  1. You do not apply a finished product label to food products manufactured and distributed to independently owned franchise retail bakeries/restaurants such as mango roll cake which contains the allergens of eggs, wheat and pistachios.

ii. You did not have appropriate controls in place for ensuring protection of food from allergen cross-contact (see 21 CFR § 117.135(c)(2)(i)). During the inspection, our investigator observed:
  1. On October 18, 2024 an employee lifted a (b)(4)-gallon sized stainless steel mixing bowl containing tuna salad product from the ground onto a flat cart with gloved hands. Apparent tuna salad residue was observed on the employee’s gloved hands. Then the employee directly touched and picked up coconut flakes in their gloved hands and sprinkled them onto RTE mango roll cake. The tuna salad contains the (tuna) fish allergen which is not an ingredient in the mango roll cake.
  2. On October 23, 2024, employees repackaged walnuts and pistachios into unlabeled plastic bags to be used in the manufacture of country sour cranberry walnut bread and mango roll cake, respectively. The employees were observed using shared equipment such as trey pack, stainless steel scoop and weigh station without cleaning them before switching from one tree nut to the next.

b. You did not identify and evaluate pathogen cross-contamination as a known or reasonably foreseeable hazard to determine whether it is hazard requiring a preventive control, as required under 21 CFR § 117.130(a)(1). Your facility manufactures RTE bakery products and desserts which are exposed to the environment after they exit the oven (such as while they are cooled, frosted, and decorated). After baking, the food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. Pathogen cross-contamination is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify pathogen cross-contamination as a hazard requiring a preventive control. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR § 117.135(c)(3)). Further, sanitation controls must include as appropriate to the facility and the food, procedures, practices, and processes for cleanliness of food-contact surfaces and prevention of cross-contamination from insanitary objects and from personnel to food, food packaging, and other food contact surfaces and from raw product to processed product per 21 CFR 117.135(c)(3)(i) and (ii).

i. You did not have appropriate controls in place to significantly minimize or prevent pathogen cross-contamination due to employee handling (see 21 CFR § 117.135(c)(3)(ii)). During the inspection, our investigator observed:
  1. On October 18, 2024, our investigator observed an employee in your production room exit a back door labeled as Emergency Exit carrying clear plastic bags of waste with gloved hands. Upon entering back into the production room, the employee with the same gloved hands proceeded to directly handle handfuls of coconut flakes to sprinkle on top of mango roll cake. Then, the employee was observed rolling another flat sheet pan cake into the roll shape. The employee did not change their gloves and/or wash and sanitize their hands before returning to handling the mango roll cakes.
  2. On October 18, 2024, our investigator observed an employee wiping flour from a mesh-lined table used for hand-filling raw empanada dough rounds with their gloved hands. The employee then directly touched RTE coconut flakes and RTE mango roll cake to pat down the coconut flakes into the cake. The employee did not change their gloves and/or wash and sanitize their hands before handling the coconut and mango roll cake.

In your written response dated November 22, 2024, you stated you conducted a hazard analysis which includes allergen cross-contact, undeclared allergens, recontamination with environmental pathogens, and metals. Further, you stated you created “(b)(4)”, a supplier approval program, and a written recall procedure. In addition, you provided documents including: “(b)(4)” which includes (b)(4) described as Preventive Controls Plan Overview, Allergen Control Program, and Label Review Program.

In your response, the hazard analyses for RTE ambient products, refrigerated products, and frozen cakes did not consider undeclared allergens at (b)(4) steps. We acknowledge that your Allergen Control Plan includes a monitoring procedure of “(b)(4)” and corrective action procedure of “(b)(4).” However, the corrective action procedure is incomplete in that it does not describe actions to take to correct the problem of undeclared food allergens and reduce the likelihood the problem will recur, as required under 21 CFR § 117.150(a)(2). Further, you stated in your written response that you (b)(4); however, you did not provide evidence to demonstrate that all allergens are declared on the labeling for each packaged product. The photograph you provided was of a “(b)(4)”.

In your response, the process hazard analyses for RTE ambient products, refrigerated products, and frozen cakes considered allergen cross- contact at process steps following ingredient (b)(4) steps. Allergen cross-contact was ruled out as a hazard requiring a preventive control at several process steps after ingredient (b)(4) steps due to the justification of “Allergen contamination unlikely with process control and GMPs.” However, a knowledgeable person manufacturing/processing food in your circumstances would identify allergen cross-contact as a hazard requiring a preventive control at these steps because equipment, utensils, and employees are shared for manufacturing food products with different allergen profiles on the same day. We reviewed your Allergen Control Program included in your GMP 2024 program under “(b)(4)”, it requires cleaning verification through a pre-operation visual inspection prior to line running and “(b)(4)”; however, you did not provide documentation to demonstrate that you conduct these visual inspections. Further, your Allergen Control Program does not include any corrective action procedures in the event the production line fails visual inspection, as required under 21 CFR § 117.150(a)(2).

In your response, the process hazard analyses for RTE ambient products, refrigerated products, and frozen cakes identified “(b)(4)” as a hazard requiring a preventive control at process steps following the (b)(4) step through (b)(4) step. However a step or steps in which a preventive control would be applied was not identified in the hazard analysis. We acknowledge you identified a preventive control of “(b)(4)” with “(b)(4)” in your Preventive Controls Plan Overview. However, your (b)(4) does not include written monitoring procedures defining the frequency of monitoring and how cleanliness of food contact surfaces and prevention of cross-contamination from insanitary objects and from personnel will be monitored as required under 21 CFR 117.145. We acknowledge your corrective action procedure of “(b)(4)” and note that additional actions, such as employee training, may be necessary to reduce the likelihood that pathogen cross-contamination will recur, as required under 21 CFR § 117.150(a)(2)(ii). We also noted that your “(b)(4)” preventive control did not identify verification procedures; however, you did provide an Environmental Monitoring Procedure which is the required verification activity for sanitation preventive controls under 21 CFR § 117.165(a)(3). The corrective action procedure included in the your Environmental Monitoring Procedure at “(b)(4)” includes steps to take in the event of a presumptive positive for Listeria spp. or Salmonella such as deep cleaning and reswabbing; however, additional corrective action steps are required under 21 CFR § 117.150(a)(2) such as taking appropriate action, when necessary, to prevent all affected food from entering into commerce if you cannot ensure that the affected food is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act. Further, you have not demonstrated implementation of your “(b)(4)” preventive control in that you provided cleaning and sanitation schedule record templates which were blank and did not identify if cleaning was performed and if monitoring, such as a visual inspection to evaluate the cleaning, was performed. In addition, you did not provide documentation such as analytical results from environmental monitoring to show that you are conducting verification of your cleaning process.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
1. You do not take effective measures to exclude pests from the manufacturing, processing, packing and holding areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR § 117.35(c). Specifically, insect and rodent activity was observed throughout your facility including, but not limited to the following:

Insect activity observed:

On October 15, 2024, an employee was weighing ingredients such as bakers salt, sugar, yeast, and flour to use in the manufacturing of RTE Saffron Raisin Twist in the scale room located in the Southeast area of the manufacturing facility. During the weighing operations, the following was observed:

  • Two apparent live beetles were observed on the floor next to the wall adjacent to the scale room and approximately (b)(4) inches from a container of flour and approximately (b)(4) inches from the tabletop in which flour, Lot (b)(4), was being weighed.
  • One apparent live beetle and one apparent live larva were on the floor in the corner of the scale room under three containers holding starch, rye, and brown sugar, respectively. Additionally, they were located approximately (b)(4) inches from the table used to weigh ingredients for Saffron Raisin Twist including flour, Lot (b)(4).
  • Six apparent live larvae were in the area between the wall and the baseboard in the scale room approximately (b)(4) inches from scale that was not in use at the time.
  • Two apparent live beetles were on the floor behind the table in the scale room. They were approximately (b)(4) inches from the top of the table used to prepare and weigh “EMPANADA” ingredients as described on the document located on the table at the time.

On October 16, 2024, two live apparent beetles were on the floor in the corner of the bread production room located in the (b)(4) central area of the manufacturing facility approximately (b)(4) inches from two rolling racks holding permeable paper bags of flour with Lot (b)(4).

Rodent activity observed:

  • On October 16, 2024, three apparent dry, but not brittle rodent excreta pellets (REPs) were directly on the sheet pan under bread slicer used to make croutons that would be distributed later in the week. The REPs were located approximately (b)(4) inches from the bread slicing blades. The bread slicer was in the (b)(4) corner of the manufacturing area.
  • On October 16, 2024, four apparent dry, but not brittle REPs were on the floor of the back wall behind stored product in ambient storage area approximately (b)(4) inches from bags of vanilla crème cake base, Lot (b)(4), The ambient storage area is in the (b)(4) corner of the manufacturing area.
  • On October 16, 2024, two apparent dry but not brittle REPs were on the bottom of a metal rolling cart holding trays of packaged RTE Mango Tarts and an opened cardboard box holding RTE tiramisu cups. The REPS were approximately (b)(4) inches from trays of packaged product. The cart was located near the right wall of the walk-in cooler which is in the (b)(4) corner of the manufacturing area.
  • On October 16, 2024, two apparent dry but not brittle REPs were on the bottom of a metal rolling cart holding unpackaged RTE Apple Tarts and plastic bags of RTE dressing in the walk-in cooler against the left wall. The sample was collected approximately (b)(4) inches from the RTE bags of dressing and approximately (b)(4) inches from the unpackaged RTE Apple Tarts. The walk-in cooler is in the (b)(4) corner of the manufacturing area.
  • On October 17, 2024, two apparent dry but not brittle REPs were on the floor of the bread production room between two rolling racks of prepped ingredients and a container of apparent bread starter which was next to a handwashing sink. The REPs were approximately (b)(4) inches from both the apparent bread starter and staged ingredients. This area is slightly (b)(4) near the center of the manufacturing area.
  • On October 17, 2024, four apparent dry but not brittle REPs were observed on the bottom of a metal rolling cart holding metal trays of unpackaged RTE pumpkin seed loaves in the firm’s baking production room in the center of the manufacturing area. The REPs were approximately (b)(4) inches from the unpackaged pumpkin seed loaves.
  • On October 17, 2024, four apparent moist and appeared to have a shine REPs were observed on the bottom of metal rolling cart holding metal racks of unpackaged RTE pastries including Mango Tarts and French Lemon Tarts being prepared for delivery. The REPs were approximately (b)(4) inches from the unpackaged RTE products. The cart was located near the (b)(4) wall next to loading dock doors and near the central prep area of the manufacturing facility.

Structural deficiencies observed:
Our investigator observed doors and roll up doors with gaps larger than a ¼” which can allow a route of entry for pests including, but not limited to the following areas:

  • On October 16, 2024, an approximate (b)(4) gap in the exterior door (next to the roll-up door) on the (b)(4) of the building leading into the production room. This door also leads to where you park your delivery vehicles and garbage bins.
  • On October 16, 2024, an approximate (b)(4) gap in the exterior door on the (b)(4) of the building. A flour sifter used to sift flour was observed adjacent to the door.
  • On October 16, 2024, a gap in the exterior door on the (b)(4) of the building leading into the room with walking refrigerator (b)(4).
  • On October 16, 2024, an approximate (b)(4) gap in the double doors on the (b)(4) of the building which lead to the outside where trash cans are held. They also lead into the ambient storage area. A pallet of dry ingredients was approximately (b)(4) feet from the doors.
  • On October 17, 2024, an approximate (b)(4) gap along the bottom of the exterior roll up door on the (b)(4) of the building that leads to the outside of the building where unused furniture and equipment were observed. It also leads into the ready to eat finished product packaging area. A rolling rack holding ready to eat bread loafs was approximately (b)(4) feet from the door.

Samples:
FDA collected two samples during the inspection (numbers 1232552 and 1269597). These samples were submitted to FDA laboratories for analysis. The filth samples demonstrated the presence of rodents and insect activity throughout the facility through the presence of rodent hairs, in pellet morphology, and confirmed various species of insects at larval, pupae and adult stages.

In your written response dated November 22, 2024, you stated you cleaned and sanitized all containers that held bakers salt, sugar, yeast, and flour as well as implemented a cleaning and sanitizing schedule to keep the scaling and production rooms clean and free of pests. You also provided a photograph to show 8 holding containers were cleaned, written GMP Program 2024 and cleaning and sanitation schedule record templates for departments: “(b)(4)”, “(b)(4)” and “(b)(4)”. The templates provided do not demonstrate that you are implementing your cleaning and sanitizing programs as defined in your written GMP Program 2024. Further, you stated in your written response that Orkin Pest Control will perform a “(b)(4). We acknowledge this is an appropriate corrective action plan; however, you have failed to provide documentation to demonstrate Orkin Pest Control conducted a thorough evaluation, outcomes of their evaluation and/or implementation of their recommendations.

2. Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials as required by 21 CFR § 117.35(a). Specifically:

On October 17, 2024, an employee was observed using a high-pressured nozzle attached to hose to rinse an aluminum baking sheet which was resting directly on the floor trench drain of your washroom. The water from the high-pressured nozzle was observed spraying directly onto the floor which had missing and broken tiles and back splashing directly onto the aluminum baking sheet. This baking sheet was then used to hold exposed RTE Walnut Pumpkin Bread lined with permeable paper loaf liners. In addition, prior to the rinsing operation, the employee was observed not using detergent and sanitizer on the aluminum baking sheet.

In your written response dated November 22, 2024, you stated you implemented a (b)(4) and conducted Good Manufacturing Practices training. You provided the following documentation: “(b)(4)” procedures, a cleaning and sanitation schedule record template for “(b)(4)”, GMP Program 2024, a GMP Training Presentation, and Training Records dated November 11-14, 2024. We reviewed the documentation provided and found the post-operational, pre-operational and operational sanitation procedures included in your “(b)(4)” procedures and GMP Program 2024 discuss breaking down of equipment and placing parts into soaking tubs, and use of foaming cleaner and sanitizer; however, the procedures do not address where and how to clean trays and utensils. Further, your GMP Training Presentation did not address your cleaning and sanitizing processes to demonstrate your employees were trained to your current (b)(4). In addition, you have not demonstrated that you are implementing your (b)(4) in that the cleaning and sanitation schedule record provided was a blank template.

3. You failed to store and transport food under conditions that will protect against allergen cross-contact and against biological, chemical (including radiological), and physical contamination of food, as well as against deterioration of the food and the container as required under 21 CFR § 117.93. Specifically:

On October 18, 2024, our investigator observed that you did not deliver RTE refrigerated vacuum packaged tuna salad products under refrigeration to protect against biological contamination of food. Your Plant Manager stated your drivers remove the finished RTE refrigerated vacuum packaged tuna salad products from the (b)(4) Walking Cooler” at (b)(4)AM, load it into your unrefrigerated trucks at (b)(4)AM and deliver to your customers between (b)(4)AM and (b)(4)AM. Furthermore, your Plant Manager stated that he was aware that the RTE refrigerated vacuum packaged tuna salad products were delivered in unrefrigerated vehicles with an approximate cumulative time of (b)(4) hours from staging to when the last customer receives the product.

In your written response dated November 22, 2024, you stated you purchased and began using refrigerated containers for the delivery of your RTE refrigerated vacuum packaged tuna salad product to maintain it at refrigerated temperatures. We acknowledge that you provided photographs of closed red portable coolers and an open cooler to show it held packages of tuna salad product and packages of deli meat inside. However, you did not provide a cooler specification sheet defining its time and temperature capability to ensure your RTE refrigerated vacuum packaged tuna salad product will be held at refrigerated temperatures for the duration of your loading and delivery processes. Further, you stated you are maintaining temperature logs for “(b)(4)”; however, you did not define the temperature critical limits/parameters for which you are monitoring. In addition, you only provided an example of a “(b)(4)” record which showed temperatures at store arrival, but it did not define what was measured and how it was measured. Further, temperatures were provided for three days, Monday, Wednesday, and Friday. There was no explanation if the record was specific to a Monday, Wednesday, Friday delivery route or why Tuesday and Thursday were not included. Records were not provided to show you are measuring the temperature of the tuna salad product at (b)(4).

Misbranding Violations

1. Your Tuna Salad and Saffron Raisin Twist products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels, if any, fail to accurately declare major food allergens, as required by section 403(w)(1) of the Act. Specifically, your Tuna Salad product is manufactured using tuna and mayonnaise (which contains egg), but the major food allergens tuna and egg are not listed on the finished product label. Your Saffron Raisin Twist product label indicates that the product contains “Egg, Milk, Flour, Almond”. For the flour ingredient, it fails to declare the name of the food source from which the major food allergen is derived from on the label, which in this case is “wheat”.

Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines “major food allergens” as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:

  • The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]: or
  • The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].

2. Your Tuna Salad and Saffron Raisin Twist products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, if any, as required under 21 CFR § 101.4. Specifically, these products are not labeled with an ingredient statement.

3. Your Tuna Salad and Saffron Raisin Twist products are misbranded within the meaning of Section 403(e)(2) [21 U.S.C. § 343(e)(2)] because they fail to bear an accurate statement of the net quantity of contents, as required by 21 CFR § 101.7.

4. Your Tuna Salad and Saffron Raisin Twist products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels, if any, fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR § 101.5(a).

In your response received via email on November 22, 2024, you stated that you (b)(4). This is not an adequate response because the finished product is not labeled with the allergens and other required labeling information.

The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including applicable FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

In addition to the violations described above, we offer the following comments:

Your written response indicated your Plant Manager was scheduled to attend “Basic GMP and HACCP Training” on December 4, 2024 and you provided a receipt to show confirmed registration. We note that the course is not specific to Seafood HACCP and therefore, may not cover potential hazards specific to fish and fishery products. In addition, it appears the course does not meet the PCQI training requirement of 21 CFR § 117 in that it may not cover all requirements of the food safety plan and may only focus on process controls and not address sanitation and allergen preventive controls and supply chain.

Please notify FDA in writing within fifteen (15) working days of receipt of this letter, of the specific steps and corrections you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Kimberly Lichter, Compliance Officer, via email at kimberly.lichter@fda.hhs.gov. If you have any questions regarding this letter, you may contact Kimberly Lichter, Compliance Officer, via email at kimberly.lichter@fda.hhs.gov. Please reference 706794 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Maria S. Knirk, JD, MBA
Acting Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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