- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameStephen A. Simmons
- Gourmet Catering to Go, LLC
801 Hangar Lane, Hanger 7
Nashville, TN 37217
- Issuing Office:
- Office of Human and Animal Foods Operations-East V
February 3, 2020
Reference No. # 596099
Dear Mr. Simmons:
The U.S. Food and Drug Administration (FDA) inspected your airline catering facility, located at 801 Hangar Lane, Hanger 7, Nashville, Tennessee, from September 27 – October 17, 2019, dates not all-inclusive. During our inspection of your facility, FDA investigators found serious violations of 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).
Based on FDA’s inspectional findings, we have determined that the RTE products manufactured in your facility 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)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or 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, C, D, E, F, and G of part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's Internet home page at http://www.fda.gov.
FDA’s inspection resulted in issuance of an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during the inspection. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not conduct a hazard analysis for any of your products to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured or processed at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a). Specifically,
a. You did not identify allergens as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. Your facility receives, stores, and manufactures various products that contain allergens such as fish, dairy, tree nuts, eggs, and ground nuts.
b. You did not identify biological hazards such as Escherichia coli 0157:H7, Listeria monocytogenes, and Salmonella as known, or reasonably foreseeable hazards associated with raw ingredients to determine whether they are hazards requiring a preventive control. Your facility receives various products such as salmon, spinach, and peppers. These ingredients have been known as a common source of biological hazards.
c. You did not identify environmental pathogens, such as Listeria monocytogenes and Salmonella, as a known or foreseeable hazard to determine whether environmental pathogens are a hazard requiring a preventive control. Your facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen or control by the supply chain or downstream customer) that would significantly minimize the pathogen.
2. 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 [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).
3. You did not prepare, or have prepared, and did not implement a food safety plan for the food manufactured in your facility, such as RTE salads, as required by 21 CFR § 117.126. A food safety plan 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).
At the conclusion of the inspection, you stated that you would conduct a hazard analysis, develop a food safety plan, and contact a third party to conduct environmental monitoring. You have not provided information that these corrective actions have been completed.
Current Good Manufacturing Practice (Subpart B):
1. All persons working in direct contact with food, food-contact surfaces, and food packaging-materials did not conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR 117.10(b). Specifically,
- An employee was observed handling a trash can and then assembling RTE garden salads with the same gloved hands without changing gloves or washing and sanitizing hands.
- An employee was observed handling raw salmon and then handling romaine lettuce for the RTE salads without changing gloves or washing and sanitizing hands.
- An employee was seen taking a smoke break outside on the dock with a soiled apron on. The same employee returned to work and handled clean dishware with the same apron on without washing and sanitizing hands and changing the soiled apron.
- Multiple employees with visible facial hair were observed cutting vegetables and performing other food handling tasks without hair or beard covers.
2. You did not store cleaned and sanitized equipment and utensils in a manner that protects food contact surfaces from allergen cross-contact and from contamination, as required by 21 CFR 117.35(f). Specifically,
- White plastic bins where clean dishes are stored were observed to be soiled with food debris and one contained a dead fly.
- Manufacturing utensils were stored on baking pans when not in use. These baking pans were observed to be soiled with old food debris.
- Dirty dishes were observed stacked on a cart that also housed clean dishes and utensils.
3. You did not maintain your plant in a clean and sanitary condition, as required by 21 CFR § 117.35(a). Specifically,
- A black mold-like substance was observed in an approximate 3-foot by 1-foot area above a small sink next to the dishwasher. This sink is located in the processing room and is used to rinse dishes and utensils before loading them into the dishwasher.
- Dust build-up was observed on the refrigeration unit fan. This fan blows air directly onto uncovered fruits and vegetables.
- A white mold-like build up was observed on several racks in the to-go cooler and kitchen storage areas. The to-go cooler is used to store food which has been prepared and is ready for delivery.Food wrappers, packaging material, dust and spider webs were observed under storage shelves and on the floor throughout the facility.
- A white mold-like build up and old food debris were observed on the lower shelf of food preparation tables. These shelves are used to store various food ingredients.
- Ceiling debris was observed on boxes of prepacked foods, food containers, and canned beverages, as well as food contact surfaces such as serving trays and ice buckets
You hired a third-party cleaning service to conduct a deep cleaning of the entire facility before the end of the inspection. However, you have not addressed how you will ensure you facility is maintained in a clean and sanitary condition.
4. You did not take effective measures to exclude pests from your food plant and to protect against contamination of food by pests, as required by 21 CFR 117.35(c). Specifically,
- Apparent rodent excreta pellets were observed in the storage area near food containers and lids along the side of the walk-in freezer.
- House flies and fruit flies were observed throughout the facility. A fruit fly and house fly were observed on baked RTE brownies. A house fly was observed on lettuce used to make garden salads. A fruit fly was observed on a clean spatula and a house fly was observed on a knife used to prepare ready to eat foods.
- Dead roaches were observed in the kitchen area along the wall across from the food prep tables near the roll-up delivery door, in the storage area next to boxes of packaged RTE snack food items, and in the men’s restroom.
- An approximate ½ inch by 8-inch gap and a ½ inch by 12-inch gap were observed on the side of the rolling dock door, allowing for possible pest entry.
- A screwdriver was observed to be used to prop open the door providing access to the hangar and outside area, allowing for possible pest entry. Apparent rodent excreta pellets were observed near this door.
You purchased (b)(4) insect lights to control flies in your facility and indicated via e-mail dated November 16, 2019, that you replaced the gasket on the rolling dock door and removed the screwdriver from the back door to hangar. You did not include photographs or work orders showing the repairs had been made or how you will prevent the reoccurrence of similar problems in the future. The adequacy of these corrective actions will be verified during a future inspection.
5. You did not conduct all food holding under such conditions and controls as are necessary to minimize the potential for allergen cross-contact, contamination of food, and deterioration of food, as required by 21 CFR 117.80(c)(2). Specifically,
- A bucket of egg yolks was observed to have apparent red blood on the top of the lid that leaked from the raw meat stored above it in the cooler.
- A mesh bag of potatoes was observed to be stored on the floor in the cooler.
- Several boxes containing food and several single packages of food, including a bag of hummus, were observed directly on the floor in the freezer.
You hired a cleaning service to conduct a deep cleaning of the facility, and you cleaned out your cooler and freezers. However, you have not addressed how you will maintain this corrective action to prevent its reoccurrence.
This letter is not intended to be an all-inclusive list of deficiencies in your plant. You are responsible for ensuring your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable regulations. You should take prompt action to correct the violations described in this letter and to establish procedures to ensure these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. 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 corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Section 743 of the FDCA (21 U.S.C. 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 noncompliance 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, assessing and collecting the re-inspection fees [21 U.S.C. 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs to your facility.
If you have questions regarding the content of this letter you may contact Zada L. Giles, Compliance Officer, either via telephone at 615-366-7985, or via email at ORAHAFEAST5FirmResponses@fda.hhs.gov
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East