- Delivery Method:
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- Food & Beverages
Recipient NameMs. Doreen Chin
- Sweet Production Inc.
915 Terminal Way, Ste B
San Carlos, CA 94070
- Issuing Office:
- Division of Human and Animal Food Operations West V
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
June 17, 2019
Ms. Doreen Chin, President
Sweet Production, Inc.
915 Terminal Way, Ste B
San Carlos, CA 94070
Reference Case # 578494
Dear Ms. Doreen Chin:
The United States Food and Drug Administration (FDA) inspected your bakery located at 915 Terminal Way, Ste B, San Carlos, CA on February 19-22, 25, 27, and Mar 04, and 06, 2019. During our inspection, FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule [Title 21, Code of Regulations Part 117 (21 CFR part117)] (CGMP & PC rule). Based on FDA’s inspectional findings observed during the inspection, we determined that food manufactured in your facility is 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 it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or 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, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)).
FDA also reviewed the labeling for your Strawberry Cupcake, Lemon Poppy Muffin, and wholesale products and determined that they are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] as detailed below. You can find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
On February 20, 2019, a sample INV1091708 was collected and confirmed that some of your raw ingredients contained foreign objects and insects and that your raw material storage area contains rodent excreta.
We have received your written response dated March 26, 2019, concerning our investigators’ observations noted on the FDA-483, Inspectional Observations, issued to you on February 11, 2019. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violations, noted below.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
The CGMP & PC rule creates new requirements for covered facilities to perform a hazard analysis and establish and implement risk-based preventive controls for human food. The CGMP & PC rule provides that you must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control [21 CFR § 117.130(a)]. The CGMP & PC rule further provides that you must 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 [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). Preventive controls are subject to preventive control management components 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).
The CGMP & PC rule requires a food safety plan (21 CFR § 117.126), which must include the following:
(1) The written hazard analysis, as required by § 117.130(a)(2);
(2) The written preventive controls, as required by § 117.135(b);
(3) The written supply-chain program, as required by subpart G;
(4) The written recall plan, as required by § 117.139(a);
(5) The written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a)(1);
(6) The written corrective action procedures, as required by § 117.150(a)(1); and
(7) The written verification procedures, as required by § 117.165(b).
However, you do not have a written food safety plan. Specifically, you did not prepare, or have prepared, and did not implement a food safety plan for the different ready-to-eat (RTE) bakery products you manufacture, as required by 21 CFR § 117.126. You must evaluate your products for biological hazards, including microbial hazards such as environmental pathogens and other pathogens, chemical hazards including unapproved color additives and food allergens, and physical hazards such as stone, glass and metal fragments.
Your response states that you intend to enroll in a FSPCA and PCQI training. You also indicate that you will follow a Food Safety Plan and that you plan to seek help from a HACCP professional. We are unable to fully evaluate the adequacy of these corrections because you did not provide any details regarding the steps you will take. We note that you have been required to comply with the preventive controls requirements in the CGMP & PC rule since September 18, 2017.
Current Good Manufacturing Practice (Subpart B):
1. You did not take effective measures to exclude pests from the manufacturing, processing, packing and holding areas to protect against contamination of food on your premises by pest, as required by 21 CFR 117.35(c). Specifically, during our inspection our investigators observed insects, sampled and confirmed by FDA analysis to be such, from two bins containing open bags of ingredients (desiccated coconut, pastry flour, whole brown baked flax seeds, all-purpose dough improver, and pure dark rye flour). Rodent excreta was also observed in the dry ingredient storage area. Fly-like insects were observed flying in the production area and landing on finished product. One of your loading dock roll-up doors was seen with multiple gaps approximately 1” wide between the bottom of the door and the floor, which allows rodents and other pests access directly to the ingredient storage room.
Your response states that the ingredients were discarded, and a pest control company serviced your facility. However, you did not provide evidence (i.e., pictures, invoices, pest reports) that corrective actions were taken. We will evaluate and verify the adequacy of your corrective actions during our next inspection.
2. You did not clean all food contact surfaces, including utensils and equipment, as frequently as necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR 117.35(d). Additionally, you did not maintain food-contact surfaces to protect food from allergen cross-contact, as required by 21 CFR § 117.40(a)(6). Specifically, we observed the following:
a. Your cutting boards used to prepare products were scarred and heavily stained with a dark residue, and the plastic containers used to hold and dispense various dry ingredients were observed cracked, some being held together with blue tape, and encrusted with residue from previous use. The equipment did not appear to have been cleaned prior to each use.
b. An ice cream scoop, used to fill lemon poppy muffins which contain almonds and wheat flour, was seen stored in a bucket of water and then used to fill gluten free muffins, which do not contain almonds or wheat flour, without being cleaned between uses.
c. You prepare products with raw ingredients on the same wooden table that finished products are prepared for further processing and packaging. For example, during the preparation of your scone recipe, an employee cracked eggs which dripped onto the same table on which baked cakes are directly placed before packaging. You said this table is only wiped with a wet cloth (water only) between uses.
The observed condition and use of these materials, as well as inadequate cleaning procedures, may contribute to allergen cross-contact and contamination.
Your response states that you replaced the cracked bowls and ordered new cutting boards to replace the stained cutting boards. However, you did not provide evidence that corrective actions were taken, nor did you address your lack of cleaning measures, utensil storage, or other maintenance activities to protect against allergen cross-contact. If you have fully implemented these corrections, you may provide documentation of such with your response to this letter. We will evaluate and verify the adequacy of your corrective actions during our next inspection.
3. Your floors are not constructed in such a manner that they may be adequately cleaned and kept in good repair, as required under 21 CFR 117.20(b)(4). Specifically, during the inspection our investigators observed standing water and pitted floors with exposed aggregate, immediately adjacent to clean equipment on shelves.
Your response did not address this violation. If you have implemented corrective actions, you may submit documentation of such in your response to this letter. We will verify your corrections during our next inspection.
4. You did not to take reasonable measures and precautions to ensure all employees working in direct contact with food, food-contact surfaces, and food packaging materials conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and contamination of food, as required under 21 CFR 117.10(b). Specifically, our investigators observed the following:
a. Employees’ personal food items were interspersed throughout your processing facility, including a partially consumed soda bottle stored directly on top of an opened bag of dry ingredients, and a small stereo placed on a wire shelf above open containers of spice ingredients.
b. An employee handled ‘S Bear Claw’ which contains almonds, and then handled ‘S Danish Pain Aux Rasins,’ which does not contain almonds, without washing and sanitizing his gloves in between.
Your response states that employee food items were removed from the work area, and you intend to conduct employee sanitation procedures training. However, you did not provide any evidence these corrections had been achieved or provide details of training content or a timeframe for completion. If you have fully implemented these corrections, you may provide documentation of such with your response to this letter. We will evaluate and verify the adequacy of your corrective actions during our next inspection.
5. You did not ensure employees receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene as appropriate to the food, the facility and the individuals assigned duties, as required by 21 CFR 117.4(a) and (b)(2). Specifically, you told our investigators that you do not have a training program for employees. Employees were observed using practices which are not consistent with CGMPs, for example: donning gloves without first washing hands, storing cleaning equipment in the handwashing sink, and using the handwashing sink to wash lemons during production.
Your response states that you created hand washing stations and sanitizers separate from the equipment cleaning sink and developed procedures to clean and sanitize hands before glove use. However, you did not provide any documentation to show training had been completed or indicate when it will be completed. If you have fully implemented these corrections, you may provide documentation of such with your response to this letter. We will evaluate and verify the adequacy of your corrective actions during our next inspection.
We note that you do not provide product labeling, including ingredient listing, for any product unless requested. When requested, this information is attached to the invoice. Your written response did not indicate any change in this practice. As such, the following charges apply:
1. Your wholesale 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 fail to accurately declare major food allergens, as required by section 403(w)(1) of the Act. Specifically, you use a box to package a variety of your products for wholesale distribution. This box states “Product contains: Egg, Milk, Wheat, Peanut and other tree nut that may cause allergy to certain individual.” This statement is not accurate for all products packaged in this box.
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, and soybeans, 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 Lemon Poppy Muffin, Strawberry Cupcake, and all wholesale products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically:
- Your Muffin – Lemon Poppy product is manufactured with Lemon emulsion which is comprised of other ingredients (sub-ingredients) which are not listed on your product label.
- 21 CFR 101.4(b) does not permit indiscriminate listings of ingredients by a collective (generic) name even though we note that each collective (generic) name is followed by the specific ingredient(s) in parenthesis, such as “emulsifier” in the Muffin – Lemon Poppy product, and “emulsifier,” “thickening agents,” and “acidity regulators” in the Cupcake - Strawberry product.
- The ingredient “egg white raw fresh” does not appear to be an appropriate common or usual name for this ingredient in the Cupcake – Strawberry product.
- Your wholesale products are fabricated from two or more ingredients and the common or usual name of each ingredient and any sub-ingredients are not declared on the label, as required under 21 CFR 101.4.
According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
3. Your Lemon Poppy Muffin product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product contains artificial coloring but fails to bear labeling stating that fact. Specifically, your Muffin – Lemon Poppy product is manufactured with lemon emulsion which uses Yellow 5 as a color additive. However, the product does not bear a label identifying the presence of this color additive using its listed name or appropriate abbreviation, as required under 21 CFR 101.22(k)(1).
4. Your wholesale products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food, as required by 21 CFR 101.3.
5. Your wholesale products are misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because their labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7.
6. Your wholesale 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 fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).
Adulteration – Color
7. Your Lemon Poppy and Strawberry Cupcake Muffin products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the products bear or contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379e(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive listing regulation. Specifically:
- The listing regulation for FD&C Yellow No. 5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use in accordance with 21 CFR 74.705(d)(2). Your Lemon Poppy Muffin uses Calemulsion (Lemon emulsion) which is labeled to contain Yellow 5, but you do not list Yellow 5 in the ingredient statement for this product.
- Your Strawberry Cupcake uses the ingredient, Strawberry Jam, which is comprised of multiple ingredients. One such ingredient is “Allura Red” identified as a coloring. When certified, Allura Red is FD&C Red #40. However, the lack of such declaration indicates that the Allura Red used in this ingredient is not certified and therefore is an unsafe color additive.
Failure to Register Food Facility
We have determined that your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d], and our implementing regulation at 21 CFR Part 1, Subpart H. During the inspection of your facility located at 915 Terminal Way, Ste B, San Carlos, CA from February 19-22, 25, 27, and Mar 04, and 06, 2019, you were advised of this requirement. Failure to register a facility as required is a prohibited act under section 301(dd) of the Act [U.S.C. § 331(dd)]. (b)(3)
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are following the law.
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or about your products. It also does not indicate that FDA has conducted an all-inclusive review of all the products you manufacture and/or distribute. It is your responsibility to ensure the products you manufacture and/or distribute are following all applicable statutes and regulations, including the Act and applicable FDA regulations. You should take prompt action to correct all the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and the occurrence of other violations. Failure to correct and prevent these violations, or similar ones, may result in FDA taking regulatory action, including, without limitation, seizure or injunction.
Within fifteen (15) business days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)].
For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related to costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection related costs.
Please send your written response to the attention of:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference Case#578494
If you have questions regarding this letter, please contact Tammy Hancock at 510-337-2922 ext 103.
Darla R. Bracy, District Director
Office of Human and Animal Food
Division 5 West
cc: Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capital Avenue – MS7602
P. O. Box 997413
Sacramento, California 95899-7435