- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Yuriy (NMI) Normatov, Ms. Zoya (NMI) Normatov
- Crispy Delight Corp.
3521 41st Street
Long Island City, NY 11101-1413
- Issuing Office:
- Division of Human and Animal Food Operations East I
158-15 Liberty Avenue
Jamaica, NY 11433
CMS # 585315
Dear Mr. and Ms. Normatov:
The United States Food and Drug Administration (FDA) inspected your Ready-to-Eat (RTE), baked goods manufacturing facility located at 3521 41st Street, Long Island City, NY 11101-1413 from April 9 through April 25, 2019. The inspection, which focused on your ready-to-eat (RTE) doughnuts and pastries, revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, [Title 21, Code of Federal Regulations, Part 117 (21 CFR 117)] (CGMP & PC rule).
Based on FDA’s inspectional observations, we have determined that during that inspection you were processing your RTE products under conditions that cause your RTE products to be 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 your RTE products 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, C, D, E, F, and G of part 117) is prohibited by Section 301(uu) of the Act [21 USC 331(uu)]. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
We received your responses dated May 26, and June 19, 2019 (hereinafter “responses”) to the FDA Form 483 issued on April 25, 2019, which included a summary of corrective actions taken and planned by your firm. The adequacy of your firm’s promised corrective actions is discussed below and implementation of those actions will be assessed during our next inspection.
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 (see 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);
(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).
During our inspection we determined that you did not prepare, or have prepared, and did not implement a food safety plan (FSP) for the food manufactured in your facility, such as RTE doughnuts and pastries, as required by 21 CFR § 117.126, including conducting a written hazard analysis as required by 21 CFR § 117.130.
In your response dated June 19, 2019, you submitted your draft FSP that includes a hazard analysis for food products manufactured in your facility. We note that your FSP only has process controls (frying/baking) for microbial hazards. Your hazard analysis frequently lists measures such as a supplier program, allergen management program, and sanitation program (which you specify as prerequisite programs, but which 21 CFR part 117 requires as preventive controls when such programs significantly minimize or prevent hazards) as justification for why a hazard does not require a preventive control.
In particular, we are concerned about how you account for food allergen hazards in your plan. You indicate you control allergen cross-contact with scheduling, but you do not indicate that you use preventive controls such as sanitation controls to significantly minimize or prevent food allergens as required by 21 CFR 117.135(c)(3). Your “Sanitation Preventive Control” on page 34 refers to biological hazards but not to food allergens. You state that scheduling “manages the introduction of common allergens to equipment contact surfaces in the order of (b)(4), ensuring no allergen changeover cleaning is needed throughout a day’s production,” but the scheduling provided in your FSP does not eliminate the need for sanitation controls to prevent allergen cross-contact. Within categories (e.g., Danish, muffins, donuts), there are varieties that contain an allergen (tree nuts) not contained in other varieties within the category. For example, all your Danishes are listed in your production schedule as “Order #3”; your Danishes include one variety with a unique allergen – pecan (in honey pecan Danish) – which would require a different schedule from the varieties that do not contain pecan unless sanitation controls are used to prevent cross-contact of the fruit Danish by the honey pecan Danish. Similarly, “Order #5” includes banana nut muffins that contain walnuts, which are not an ingredient in the other muffins in the “Order #5” group. Muffins/Yogurt are also scheduled as another group of “Order #5”; two of these muffins contain unique allergens – almonds in cranberry almond and coconut in coconut pineapple varieties. You do not consider your sanitation activities to be preventive controls but state that “monitoring information for sanitation and supply chain controls are being maintained in the case that they are added to the plan at a later date.”
We also have concerns about your “validation” for the frying/baking/product temperatures at your process preventive control. You did not provide the scientific basis for the temperature being adequate to control the hazard of microbial pathogens you identified in your ingredients. On page 32, the “Process Preventive Control” table of your FSP states for validation, “no customer complaints received due to food borne illness” and on page 39 the table, “Verification & Validation of Food Safety Plan” notes for “Oven & product Temperature Control” that the method used includes, “lack of customer complaints that can be traced back to improper temperature control.” The latter table also includes replacing (b)(4) and (b)(4) calibration of the reference thermometers, which are appropriate for ensuring the temperatures of the oven and product are accurate, but you did not provide a justification that the temperatures and times of your baking process are adequate to significantly minimize the microbial pathogens you identified in your hazard analysis as requiring a preventive control (the “process preventive control/baking/frying temperature”).
Current Good Manufacturing Practice (Subpart B):
1. You did not take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests as required by 21 CFR 117.35(c). Specifically, on April 9, 2019, the following conditions were observed:
o Over two hundred (200) cardboard boxes were examined throughout your firm’s packaging areas, and pest activity was found on, around, and within these boxes. This pest activity included approximately fifteen (15) rodent-like nests with rodent-like nesting material, rodent-like gnaw marks, apparent Rodent Excreta Pellets (REPs) too numerous to count (TNTC), rodent-like hairs, one (1) live apparent rodent, and eleven (11) live apparent juvenile rodents.
At 10:15 AM, five (5) live apparent juvenile rodents were observed in an apparent rodent nest in the Northeast corner of the packaging room in the bottom-most cardboard box within a stack of cardboard boxes used as packaging material for RTE doughnuts. Additionally, open and exposed RTE food (doughnuts and pastries) were observed being packaged on shelves adjacent (less than one (1) foot away) from where the apparent rodent nest was located.
At 1:15 PM, seven (7) live apparent juvenile rodents were observed in an apparent rodent nest in the Northeast corner of the packaging room in the bottom-most cardboard box within a stack of cardboard boxes used as packaging material for RTE doughnuts. Additionally, open and exposed RTE food (doughnuts and pastries) were observed being packaged on shelves adjacent (less than one (1) foot away) from where the apparent rodent nest was located.
o REPs TNTC were observed on and around bags of food ingredients staged on pallets located in the main open packaging area and behind the doughnut mixers.
o An approximate 3-5” gap was observed at the bottom of the loading door along the (b)(4) wall of the facility and leading into the packaging room.
o An approximate 2-3” hole was observed behind the oven control panel. The oven control panel (b)(4) proof boxes in the doughnut room and oven room were noted as having 1-2” gaps along the uneven pitted and grooved floor.
o Food matter, debris, and refuse were noted throughout the facility on the floors, in crevices, against walls, and underneath storage shelves used to hold packaging material, ingredients, and RTE finished foods. Pest harborage areas included refuse and stacks of cardboard boxes.
o Two pest stations were observed directly on the doughnut machine (located along the (b)(4) wall of the facility) and underneath the conveyor. The traps inside the stations had live cockroach-like insects TNTC. RTE exposed doughnuts were observed exiting the fryer and passing on the conveyor directly over (less than two (2) feet above) the pest stations with live insects TNTC.
o The (b)(4) proof box located in the doughnut prep room had a double door with a rubber gasket around the edge of each door. When the rubber gasket was peeled away from the right door (facing the proof box), several live cockroach-like insects were observed between the rubber gasket and the proof door. Several racks of work in process dough were observed inside the proof box at the time.
o Live cockroach-like insects TNTC and REPs TNTC were observed in the doughnut machine proof boxes (along the Eastern wall of the facility) where exposed work in process dough was observed proofing. Numerous REPs TNTC were observed on the floor immediately around the doughnut machine proof boxes.
o Live cockroach-like insects TNTC were observed in the oven control panels located in the oven room where work in process and finished food products were being stored and handled.
o REPs TNTC were observed on a shelf in the pastry prep room. The shelf was mounted on a wall in the Southeast corner of the room and located directly above where work in process dough was being sheeted. The dough exited the sheeting machine on the table directly underneath the shelf with REPs TNTC.
The FDA sample INV 1089469, collected during the inspection on April 9, 2019, and consisting of 8 subsamples collected throughout your facility (including processing, packaging, and storage areas) was analyzed by FDA’s Northeast Food and Feed Laboratory. The analysis confirmed the presence of rat excreta pellets, rodent gnawing and rodent hairs (rat and mouse). The visual observations and the analytical results for this sample confirm the presence of rodent activity within your facility.
2. Your firm did not have appropriate quality control operations to ensure that food is suitable for human consumption and food packaging materials are safe and suitable as required by 21 CFR 117.80(a)(2). Specifically, on April 9, 2019, the following conditions were observed:
Over two hundred (200) cardboard boxes were examined in your firm’s RTE food packaging areas. The cardboard boxes were being used as packaging material (direct food contact surfaces) for your firm’s finished RTE food products. Investigators observed pest activity on, around, and within these cardboard boxes. The pest activity included approximately fifteen (15) rodent-like nests with nesting material, rodent-like gnaw marks, apparent Rodent Excreta Pellets (REPs) TNTC, rodent-like hairs, one (1) live rodent, and eleven (11) live apparent juvenile rodents.
Filth was observed directly within and on the same RTE food packaging, including refuse, debris, stains, accumulation of food matter, and one (1) (b)(4) water bottle containing a yellow liquid. Several boxes were observed to be worn, bent, and/or torn.
Your firm’s normal practice is to package your RTE foods in these carboard boxes on a paper liner, and these cardboard boxes are reused (b)(4) Customers are instructed to return the boxes to your firm to be refilled as per the instructions on the boxes’ labeling. Your firm was observed packaging RTE foods, including doughnuts and pastries, within the previously used cardboard boxes. Employees were observed removing excess debris by wiping and/or shaking the debris out of the boxes before placing a liner in the boxes, and then filling the boxes with RTE foods, such as doughnuts and pastries, prior to distribution. On April 9, 2019, our investigators observed that your firm produced and packaged approximately (b)(4) dozen doughnuts and approximately (b)(4) dozen pastries in this manner.
3. You did not conduct all food manufacturing, packing, and holding under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, allergen cross-contact, contamination of food, and deterioration of food as required by 21 CFR 117.80(c)(2). Specifically, on April 9, 2019, the following conditions were observed:
Several baking trays staged on mobile baking racks and located in both the walk-in cooler and walk-in freezer and being used to hold work-in-process dough had an accumulation of apparent filth residue.
The doughnut machine proof box conveyor was observed to have a heavy accumulation of filth, debris, and caked-on food matter. Several REPs were observed on the ledges and floor of the proof box immediately next to or, in close proximity to, work in process dough.
Open and closed bags of ingredients in the dry storage areas, including pallets of doughnut dry flour mix, powdered sugar, and buckwheat were noted as having apparent REPs TNTC on and around the bags. Pallets of these ingredients were located in the main open packaging area, next to the doughnut machine proof boxes behind the doughnut mixers and staged directly against walls, hampering adequate sanitation operations. Additionally, an employee was observed picking up a bag of doughnut flour mix and placing part of the bag inside the mixer, inverting the bag and emptying the contents into the mixer. The outside of the bag was not cleaned prior to being placed inside the mixer, and the outside of the bag was observed in direct contact with the inside of the mixer as well as the ingredients in the mixer.
Plastic bins used to hold icing had plastic lids and an accumulation of filth and mold-like matter on the inside surface of the lid was observed. The lids were observed to come in direct contact with the icing. Apparent filth was observed in RTE icing used as an ingredient in the manufacture of RTE doughnuts (post frying).
Condensate and apparent filth were noted on the ceiling of the walk-in proof box. The proof box was in the oven room next to the walk-in freezer. Several racks of work in process dough were observed within the walk-in proof box, and condensate was observed dripping from the ceiling onto the trays of work in process dough.
Racks of work in process dough were observed staged directly underneath cooler fans located within the walk-in cooler and the walk-in freezer. Condensate was observed dripping directly onto trays of work in process dough and pooled on the floor in the coolers around racks of work in process dough.
The ceiling directly above the doughnut machine conveyor was noted with an accumulation of apparent filth and rust-like matter; RTE doughnuts were observed exiting the conveyor and passing directly underneath these areas. Open and exposed icing was observed also staged underneath the same ceiling area noted with apparent filth and rust-like matter.
A UV fly trap was observed directly over the mixer in the doughnut dough prep room.
4. You did not identify and hold raw materials and other ingredients that are food allergens, and rework that contains food allergens, in a manner that protects against allergen cross-contact as required by 21 CFR 117.80(b)(8). Specifically, on April 9, 2019, the following conditions were observed:
A large plastic bin of liquid egg was observed stored in the walk-in freezer without identification or allergen labeling.
A cardboard box of shredded desiccated coconut was observed in the doughnut finished stations without identification or allergen labeling.
5. Your equipment and utensils were not designed and of such material and workmanship as to be adequately cleanable and were not adequately maintained to protect against contamination as required by 21 CFR 117.40. Specifically, on April 9, 2019, work in process and finished RTE food products were observed stored on metal wire racks, within metal baking molds, and on/around metal equipment and metal food contact surfaces that were in a state of disrepair including heavy wear, corrosion, and/or rust.
6. You did not adequately maintain buildings, fixtures, and other physical facilities in a clean and sanitary condition or in repair adequate to prevent food from becoming adulterated. Further, you did not clean and sanitize utensils and equipment 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 April 9, 2019, the following conditions were observed:
A high-pressure water hose and nozzle were observed on the floor adjacent to the doughnut frying machine, where the floor was noted as pitted and grooved and had an accumulation of pooled water containing apparent filth. An employee was observed picking up the hose and subsequently spraying the floor and the side of the doughnut machine directly below where RTE fried doughnuts were exiting the fryer. The employee was then observed hanging the hose head and nozzle on the edge of a metal container located next to the doughnut machine. This container held RTE icing that was subsequently used to glaze RTE doughnuts.
The floors throughout your facility, including the processing and packaging area, were in a state of disrepair. The floors were observed as having deep pits, grooves, and uneven surfaces. Stagnant water with apparent filth was pooled on the floors throughout the facility.
Employees were observed pushing racks holding baking trays filled with RTE food products through the facility over uneven floor areas that were heavily pitted and grooved. On three (3) separate occasions the rack wheels hit uneven floor areas causing RTE food products, including doughnuts and pastries, to fall off the trays directly onto the floor. An employee was observed picking up fallen RTE pastries off the floor and placing them back onto the trays directly in contact with pastries that remained on the rack.
7. Your plant did not have adequate sanitary facilities and accommodations as required by 21 CFR 117.37. Specifically, on April 9, 2019, the following conditions were observed:
The doughnut prep room where employees handled work in process dough using bare hands lacked hand-washing stations. The closest hand-washing facility was located adjacent to the doughnut finishing station. This area is separate from the doughnut prep room and located approximately 20 feet from the doughnut prep area. Employees were observed handling the work in process ingredients and dough after having touched various non-food contact surfaces, equipment, and utensils without frequent hand washing in-between.
Two (2) employee restrooms located at the front of the building towards the main entrance (Northwest corner of the building) lacked a method for hand drying, and one restroom had only scalding hot water at the hand washing station.
Your responses outline corrective actions you have taken or plan to take, including the following:
Removing all packaging materials, ingredients, work in process, and finished product from the facility and purchasing single use containers for the distribution of your firm’s finished products.
Sealing exterior holes (including gaps under doors) to stop additional rodents/pests from entering the facility and interior holes to reduce the number of harborage/nesting sites available.
Enforcing the practice of maintaining closed doors (pedestrian and loading) when not in use.
Sealing/repairing all equipment with bent/torn paneling that exposed insulation and/or open space for harborage/nesting sites.
Sealing space underneath free-standing boxes with cement to eliminate potential harborage sites.
Eliminating clutter from the facility.
Using devices for catching rodents and treating for cockroaches as a secondary method to sanitation.
Using a trailer and inspecting incoming materials for all deliveries to reduce the risk of pest entry.
Designating a hold area outside of the production area to inspect any suspect products/supplies entering the facility.
Increasing pest control service (b)(4).
Conducting a facility-wide, detailed cleaning of the floor and walls, including all floor-wall junctures, shelving, and underneath equipment.
Cleaning all trays/racks, utensils, and detachable equipment components.
Conducting an extensive cleaning of all equipment, such as pulling the panels off and scraping out all debris build-up.
Patched depressions/pitting observed in the floor with cement.
Thoroughly cleaning the ceiling above the doughnut machine conveyor (underside of metal platform) of debris/residue, painting I-beams, cleaning lights and light fixtures (or replacing them if not sufficiently cleanable).
Painting a (b)(4) around the interior perimeter of the facility for ease of monitoring cleanliness and pest activity.
Working with food safety consultants to develop prerequisite programs.
Adding (b)(4) to house the dishwashing/cleaning operations.
Installing paper towel dispensers and addressing water temperature in restrooms.
Installing a hand wash station in the doughnut prep room.
You did not include adequate documentation for us to fully evaluate your responses. We will verify the adequacy of your corrective actions during a future inspection.
Color Additive Labeling
Your Cake Donut and Yeast Donut products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the products bear or contain a color additive which is unsafe within the meaning of section 721(a) of the Act [21 USC 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, according to your draft FSP, your Cake Donut and Yeast Donut products are manufactured with FD&C Yellow No.5; however, the products do not bear a label identifying the presence of this color additive.
1. All of your products, including but not limited to all varieties of donuts, scones, muffins, Danish, and turnovers, 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 declare all major food allergens, as required by section 403(w)(1) of the Act. Specifically, your products are manufactured with wheat, milk, egg, soy, almonds, walnuts, coconut, and/or pecans in various combinations. You package all of your products into cardboard boxes with a statement that “This product contains: Eggs, Milk, soy, wheat and tree nuts” regardless of the contents within. Further, the use of the term “tree nuts” is not permitted in the “contains” statement. The actual food source for the allergen must be listed.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines 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 as “major food allergens.” 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. All of your products, including but not limited to all varieties of donuts, scones, muffins, Danish, and turnovers, are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is 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, all of your products are packed in the same box which only has the “contains” statement previously mentioned. Therefore, all of your products fail to bear an ingredient statement.
3. All of your products, including but not limited to all varieties of donuts, scones, muffins, Danish, and turnovers, 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. For example, the product label fails to declare a statement of identity of the food on the principal display panel as required by 21 CFR 101.3.
4. Your Cake Donut and Yeast Donut products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the products bear or contain an artificial flavoring, coloring, or chemical preservative. In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients. According to your draft FSP, your Cake Donut and Yeast Donut products are manufactured with FD&C Yellow No.5 and FD&C Yellow No. 6; however, the product does not bear a label identifying the presence of these color additives. Under 21 CFR 101.22(k)(l), certified colors must be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter. The common or usual name may be abbreviated to omit the "FD&C" prefix and the term "No." (e.g., Yellow 5).
5. All of your products, including but not limited to all varieties of donuts, scones, muffins, Danish, and turnovers, 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). Specifically, you package your products in a cardboard box which states “Property of Nice & Fresh Inc.” which is a dba no longer used by your firm. Further the label fails to include the street address, city, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.
6. All of your products, including but not limited to all varieties of donuts, scones, muffins, Danish, and turnovers, are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product label fails 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.
Food Facility Registration
The FDA has determined that your facility located at 3521 41st Street, Long Island City, NY 11101 is subject to the food facility registration requirement. Section § 415(a)(3) of the Act requires facilities that are required to register with FDA to renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year. Our records indicate that as of the date of this letter your registration was canceled. The failure to register a facility as required is a prohibited act under Section § 301(dd) of the Act, 21 U.S.C. § 331(dd).
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 in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility's owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Food facility registration guidance is available online at www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm. Registration may be accomplished online at www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537.
This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration
Food Facility Registration (HFS-681)
5001 Campus Drive
College Park, MD 20740
When completed, the form may be faxed to 301-436-2804 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring your facility operates in compliance with the Act, the CGMP & PC rule, the seafood HACCP regulation, and other applicable requirements.
You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action without further notice, including without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non- compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re- inspection-related costs.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including photographs or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Please send your reply to the Food and Drug Administration, Attention: W. Martin Rennells, Compliance Officer, One Winner’s Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact Mr. Rennells at 518-453-2314 x 1038 or email@example.com.
Program Division Director
Office of Human and Animal Food Operations -
East Division 1