Inspections, Compliance, Enforcement, and Criminal Investigations

Gate Gourmet Inc. 3/29/18

 

  

Black HHS-Blue FDA Logo

 

 

 
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772

 

March 29, 2018
 
WARNING LETTER  543440
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Gary C. Reeves, General Manager
Gate Gourmet, Inc.
3298 Lincoln Road Unit 117
Erlanger, Kentucky 41018
 
Dear Mr. Reeves:
 
This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA) has changed the classification of your airline catering facility, located at 3298 Lincoln Road, Unit 117, Erlanger, Kentucky, from "Approved" to "Provisional" classification.
 
On November 29 and December 1, 2017, FDA conducted an inspection of your airline catering facility located at the aforementioned address. This inspection was conducted under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA) to determine your compliance with the applicable sections of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (CGMP & PC) regulation, Title 21, Code of Federal Regulation Part 117 (21 CFR Part 117) , and under the authority of the Public Health Service Act (PHS Act) to determine your compliance with applicable sections of the Interstate Conveyance Sanitation regulations (21 CFR Part 1250). The Interstate Conveyance Sanitation regulations were promulgated pursuant to Section 361 of the PHS Act (42 U.S.C. §264) to prevent the introduction, transmission, or spread of communicable diseases.
 
The inspection revealed serious violations of FDA’s CGMP & PC regulation.  These conditions cause the food products held at your facility to be adulterated within the meaning of Section 402(a)(4) of the FDCA [21 United States Code (USC) 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.
 
Section 418 of the FDCA and its implementing regulation in 21 CFR Part 117 require covered food facilities to 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 the facility will not be adulterated under section 402 or misbranded under section 403(w) of the FDCA. It is a prohibited act under section 301(uu) of the FDCA, for the owner, operator, or agent in charge of such a facility to not comply with the requirements of section 418 or the implementing regulation.
 
At the conclusion of the inspection, the FDA investigator issued a list of Inspectional Observations (Form FDA 483) to your firm. We acknowledge your firm’s response to the Form FDA 483, received December 19, 2017; these reported corrections will be evaluated during a subsequent inspection of your firm.  As documented on the Form FDA 483 dated December 1, 2017, the following are the significant deviations from 21 CFR Part 117, under the FDCA, found in your airline catering facility:
 
Your significant cGMP violations include:
 
1.    You failed to exclude pests from your food plant to protect against contamination of food, as required by 21 CFR Part 117.35(c). Specifically,
 
A.  Evidence of apparent cockroach activity and lack of effective measures to exclude cockroaches and other pests from the manufacturing and processing areas was observed during the inspection on November 29, 2017 and consisted of the following:
 
i.  One apparent live cockroach was observed on the interior side of the (b)(4) oven door located in the hot production kitchen and one apparent live cockroach was observed on the floor beneath the mechanical flight-type dishwashing machine (Machine #1) in the dishwashing room.
 
ii.  Dead apparent nymph and adult cockroaches too numerous to count were observed inside the storage compartment to the four-burner gas range in the hot preparation kitchen.  Additionally, multiple dead apparent nymph and adult cockroaches were on floors near drains and behind cooking equipment in the hot preparation kitchen and on glue traps in the employee cafeteria.
 
iii.  Unsealed water pipe penetrations with heavy apparent cockroach fecal markings were observed in the wall underneath the 3-compartment pot wash sink in the hot preparation kitchen.
 
iv.  Non-operational cooking equipment, which could serve as harborage sites for pests, were located along the cookline in the hot preparation kitchen.  These pieces of equipment had apparent old food and grease deposits throughout.
 
B.    According to your contracted pest service operator’s reports, cockroach activity was observed in and around food cooking equipment such as ovens and stoves, around manual ware washing sinks, inside and around mechanical dishwashing equipment, inside void areas of portable plastic food carts and around the employee cafeteria food lines during service inspections by a licensed pest control operator spanning from June 2 to November 2017.  Furthermore, your contracted pest service operator’s reports indicated sightings of 75 (6/12/17), 100 (7/17/17), 100 (9/22/17), 100 (10/2/17), and 200 (10/24/17) “German Roaches” located throughout the whole building during service visits on the specified dates.  During this timeframe, your firm continued to operate as an airline caterer providing meals, snacks, and beverages to commercial airlines at the
(b)(4)
 
Your response indicates you have contracted with a new pest control company, removed storage cabinets, cleaned equipment, and sealed the water pipe.  However, we cannot evaluate the adequacy of the measures you have taken because you did not provide evidence to show you are now in compliance with 21 CFR Part 117.35(c).  For example, you did not provide pest control records showing no evidence of pests, photographs of clean equipment or a sealed water pipe.  These reported corrections will be evaluated during a subsequent inspection of your firm.
 
2.    You failed to maintain equipment in an adequate condition through appropriate cleaning and sanitizing, as required by 21 CFR Part 117.80(c)(1). In addition, you failed to conduct operations under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination of food, as required by 21 CFR Part 117.80(c)(2).  Specifically,
 
A.  A heavy build-up of more than a day’s accumulation of grease, food deposits, and general filth was observed on non-food contact areas of cooking equipment in the hot preparation kitchen.  The cooking equipment included:  ovens, ranges, tilting skillet, gas grill, deep fat fryers as well as the associated components to the cooking equipment such as gas/water piping, electrical wiring, and metal structural supports.  Additionally, apparent food soil and filth was observed on legs and shelves to portable food transport carts and casters on moveable equipment in this area.
 
B.  Floors underneath equipment and walls in difficult to reach areas in the hot and cold preparation kitchens and dishwashing areas were soiled with apparent old food residue and filth. Additionally, standing water was observed in an approximate 12” X 12” section in the floor near the gas ranges where floor tiles were missing.
 
C.  Interior and exterior sides of black plastic dust pans were stored within five feet of food preparation counters and food products in the preparation kitchens with apparent build-up of food and liquid residue.
 
Your response indicates you have repaired the 12” x 12” section of tile and that you plan to retrain your employees on proper cleaning and sanitizing. However, we cannot evaluate the adequacy of your corrective actions because you did not provide evidence to show you are now in compliance with 21 CFR Part 117.80(c)(1) and (2). For example, you did not provide photographs showing the floor has been repaired, items have been cleaned, or provided training records. These reported corrections will be evaluated during a subsequent inspection of your firm.
 
3.    You failed to clean all food contact surfaces, including utensils and food contact surfaces of equipment, as frequently as necessary to protect against contamination of food, as required by 21 CFR Part 117.35(d). Specifically, during the inspection on November 29, 2017,
 
A.  Apparent food residue was observed on the blades to the large metal can openers in the hot and cold preparation rooms.
 
B.  Apparent food soil and grease deposits were observed along the juncture of the cutting board and metal housing of the gas grill in the hot preparation kitchen.  Additionally, the cutting board was in poor condition and appeared stained and soiled with food residue. 
 
Your response indicates you have removed the cutting board so that proper cleaning and sanitizing may be performed. However, your response is inadequate because it does not address the food residue build-up on the can openers. Furthermore, we cannot evaluate the adequacy of your corrective actions because you did not provide evidence to show you are now in compliance with 21 CFR Part 117.35(d). For example, you did not provide photographs showing the cutting board was removed. These reported corrections will be evaluated during a subsequent inspection of your firm.
 
4.    You failed to have adequate sanitary facilities and accommodations in your plant, as required by 21 CFR Part 117.37(b)(3).  Specifically, during the inspection on November 29, 2017,
 
A.  Water leaked from plastic drainage piping on the underside of the mechanical flight-type dishwasher (“Machine #1”) and pooled on the floor below.
 
B.  A metal floor drain in the cold preparation kitchen had a build-up of apparent old food waste and general filth inside the drain’s catch basket.  According to the General Manager, the covers to most of the floor drains including this drain, are unable to be removed due to the age of the drain in order to clean out food caught in the catch basket.
 
Your response indicates you plan to replace the PVC piping with copper and the drain grates and baskets have plans to be replaced.  However, we cannot evaluate the adequacy of your corrective actions because you did not provide evidence to show you are now in compliance with 21 CFR Part 117.37(b)(3). For example, you did not provide photographs showing the piping and drain grates were replaced, nor did you provide a timeframe for replacing the piping and drain grates. These reported corrections will be evaluated during a subsequent inspection of your firm.
 
The inspectional observations identified above are not intended to be an all-inclusive list of the conditions observed at your facility. It is your responsibility to ensure adherence with all requirements of the regulations at your servicing areas and watering points, and any other conveyances or facilities involving interstate travel and sanitation under your control.
 
Based on these inspectional findings, a "Provisional" classification has been assigned to your airline catering facility. A "Provisional" classification means that the caterer, may continue to operate; however, significant corrections of observed violations must be made. If significant correction is not made by the time of the next inspection in approximately 30 calendar days, FDA will reclassify your airline catering facility as "Non-Approved".
 
Please notify this office in writing within 15 working days from your receipt of this letter of the specific steps you have taken to correct the violations with documentation to show how correction has been achieved.  If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
 
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.
 
Your response should be sent to Kimberly A. Dutzek, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, TN 37217.  If you have any questions with regard to this letter, you may contact Kimberly Dutzek at 615-366-7826 or via e-mail: kimberly.dutzek@fda.hhs.gov.
 
Sincerely,
/S/ 
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East

Page Last Updated: 06/25/2018
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