Demetri S. Proffitt
- Demetri's Coffee Service
2103 South Highland Park Avenue
Chattanooga, TN 37404-6016
- Issuing Office:
- Cincinnati District Office
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Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772
September 25, 2017
WARNING LETTER No. 537266
UNITED PARCEL SERVICE
Delivery Signature Requested
Demetri S. Proffitt, Owner
Demetri’s Coffee Service
2103 South Highland Park Avenue
Chattanooga, Tennessee 37404-6016
Dear Mr. Proffitt:
On July 17-19, 2017, U.S. Food and Drug Administration (FDA) investigators inspected your ready-to-eat food manufacturing facility, located at 2103 South Highland Park Avenue, Chattanooga, Tennessee. This inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (cGMP) requirements in Manufacturing, Packing or Holding Human Food, Title 21, Code of Federal Regulations
, Part 110 (21 CFR 110). These conditions cause the food products held at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [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. You may find the Act through links on FDA’s Internet home page at www.fda.gov
Good Manufacturing Practices
1. You failed to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated, as required by 21 CFR 110.80(b)(3). Specifically, on 07/17/2017, multiple in-house cooler temperature thermometer checks between approximately 8pm and 10pm revealed that shelled eggs, uncooked biscuit dough, cheese, gravy and other ingredients were stored in the produce cooler at approximately 60.4 degrees Fahrenheit. Some of the tubes of uncooked biscuit dough expanded outside their packaging; some of which were observed touching the walls of the cooler
2. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must wash their hands thoroughly and sanitize if necessary to protect against contamination in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time their hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Specifically, on 07/17/2017, three employees changed their gloves without washing their hands when they changed the type of meat during manufacturing for various ready-to-eat sandwiches. Furthermore, the same employees touched non-food contact surfaces, left the room and returned to manufacture ready-to-eat sandwiches without washing their hands. Additionally, an employee touched her face several times with a gloved hand and then directly touched ready-to-eat food without washing her hands and/or changing gloves.
3. You failed to 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 110.35(c). Specifically, on 07/17/2017, live flies were observed in the production room landing on ready-to-eat sausage biscuit sandwiches and food contact surfaces throughout the inspection. Furthermore, one live apparent cockroach was observed on food processing table leg next to prep table where ready-to-eat sausage biscuits were being prepared, and one dead apparent cockroach was observed near the entrance to the produce cooler. On 07/18/2017, a live apparent cockroach was observed on the tile wall behind the cooking pot rack in the prep room before processing started. The apparent cockroach on the wall was then observed crawling across the entire processing room floor and walls. On 07/18/2017, approximately four live apparent cockroaches were observed crawling on walls and floor in the hallway adjacent to the entrance of the processing area used to transport finished ready-to-eat product to the coolers and load out room.
4. You failed to wear outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.10(b)(1). Specifically, on 07/17/2017, an employee was observed to be making ready-to-eat egg and cheese croissant sandwiches to be packaged for sale, when the top of the croissant fell onto the employee’s shirt, with no apron being worn, and the employee placed the top of the croissant back onto the sandwich and packaged it for sale.
5. You failed to have the plant constructed in such a manner as to allow floors, walls and ceilings to be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.20(b)(4). Specifically,
- Floors were observed to have apparent filth, grime, and food debris before and after sanitation practices were performed on 07/17/2017.
- In the prepping area, a hole approximately 10 inches by 5 inches was observed in the ceiling near the northwest side of the exhaust hood on 07/17/2017.
- In the cooking area, a 3 x 2 foot peeling area of the ceiling, with a 2 inch hole in the middle, was observed over a wooden prepping table on 07/17/2017.
- On 07/17/2017, condensate was observed dripping from cooling units and ceilings in the bread cooler onto various packaged bread, packaging materials, batter, and products used to manufacture ready-to-eat foods.
6. Your firm failed to properly maintain plant equipment as to be adequately cleanable and properly maintained, as required by 21 CFR 110.40(a). Specifically, wooden tables with visible seams and cracks were observed being used to prepare a variety of sausage biscuit sandwiches, burgers, and other food products on 07/17/2017.
7. You failed to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(1). Specifically,
- On 07/17/2017, heavy apparent grease residues and food residues were observed above, below, and on the sides of the fryer and griddle located in the kitchen.
- A cooking pot with buildup from apparent food residue was observed on the clean storage shelves in the processing room on 07/18/2017.
8. You failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, and food-contact surfaces, as required by 21 CFR 110.20(b)(6). Specifically, on 07/17-18/2017, multiple unscreened fans in the production room were observed, with apparent buildup of filth, blowing directly over food manufacturing areas to include fryers, sandwich building areas, and food wrapping/packaging areas during the manufacture of ready-to-eat biscuits, and sandwiches.
9. You failed to have adequate drainage of areas which may contribute to contamination of food by seepage, foot-borne filth, or by providing a breeding place for pests, as required by 21 CFR 110.20(a)(3). Specifically, a drain located in the middle of the processing floor was observed to be covered with plastic wrap on 07/17/2017. On 07/18/2017, the plastic wrap was removed from the drain and appeared to be backed up with standing water, apparent grime, and filth.
10. You failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, on 07/17/2017, approximate 0.25 inch to 0.5 inch gaps were observed on sections of lower door seals for the receiving bay door and multiple employee side entrance doors that lead into the cooler storage area and processing facility.
11. You failed to store clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed, as required by 21 CFR 110.10(b)(7). Specifically,
- On 07/17/2017, we observed several employees store their personal items such as beverages, keys, and purses on the bottom shelf of all the prep tables during the manufacture of ready-to-eat sausagesandwiches. Furthermore, employees were observed to drink from personal beverages during manufacturing.
- On 07/18/2017, we observed an employee lean against a stainless steel prep table for the meat slicer while using their cell phone in the processing room during the manufacture of ready-to-eat sandwiches.
12. Your employees failed to wear, where appropriate, in an effective manner hair nets, headbands, caps, beard covers, or other effective hair restraints, as required by 21 CFR 110.10(b)(6). Specifically,
- An employee was observed cracking eggs with no beard cover on.
- Employees were observed manufacturing ready-to-eat sandwiches, while not adequately wearing hair nets and beard covers to cover all exposed hair.
The above violations are not meant to be an all-inclusive list of deficiencies in your plant. It is your responsibility to assure all of your products are in compliance with applicable statutes enforced by the FDA. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure or injunction.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations, including an explanation of how your firm plans to prevent these violations, or similar violations from occurring again. More specifically, your response should include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Please include copies of any available documentation demonstrating corrections have been made. Your response should be comprehensive and address all violations included in this Warning Letter.
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 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 and assessing and collecting the re-inspection fees [21 USC 379j-31(a)(2)(B)]. 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.
Please send your reply to Kimberly A. Dutzek, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Suite 500, Nashville, TN 37217. If you have questions regarding any issues in this letter, please contact Ms. Dutzek via (615) 366-7826.
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East