Inspections, Compliance, Enforcement, and Criminal Investigations
Greens Wholesale Distributors, Inc. 9/13/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
September 13, 2012
WARNING LETTER NO. 2012-NOL-29
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
James C. Green, Owner
Greens Wholesale Distributors, Inc.
6955 Fish House Lane
Hixon, Tennessee 37343-4893
Dear Mr. Green:
On July 24 – 25, 2012, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, Greens Wholesale Distributors, Inc., located at 6955 Fish House Lane, Hixon, Tennessee. We found you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), and the Current Good Manufacturing Practice (CGMP) regulation for foods, 21 CFR 110. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan to comply with this section or otherwise operate in accordance with the requirements of 21 CFR 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), Title 21, United States Code (21 USC), Section 342(a)(4). Accordingly, your catfish products are adulterated, because they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links on FDA’s Internet home page at www.fda.gov.
Significant violations listed on the FORM FDA 483, Inspectional Observations, issued to you on July 25, 2012, include, but are not limited to, the following:
1. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with CGMP requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the eight areas of sanitation with sufficient frequency to ensure compliance with the CGMP requirements in 21 CFR 110, as evidenced by:
- The cutting boards on which catfish are dressed appeared to be badly pitted and stained;
- Employees did not wash their hands upon return to work after their lunch break;
- The rest room was not equipped with soap or paper towels, and the automatic hand dryer was not functioning;
- The hand wash sink was not clean, and it was in poor repair, being held up by a plastic bucket;
- Waxed cardboard boxes in which fish are packaged are stored in an open, exposed trailer on the outside grounds;
- Several unlabeled apparent chemicals were around and about the operations facility;
- Flies, too numerous to count, were present in the processing area during the production of catfish, utensils, and food contact surfaces; and,
- Numerous cobwebs were observed in the processing areas with attached dead flies.
2. Failure to properly store equipment, remove litter and waste, and cut weeds or grass which may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures [21 CFR 110.20(a)(1)]. For example, on July 24, 2012, the facility grounds were littered with containers, tall grass, pallets and trash. We acknowledge your attempt to correct the appearance of the facility on the second day of the inspection; however, this is a violation noted in previous inspections.
3. Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition [21 CFR 110.35(a)]. The ceiling of the food processing area is in poor repair. It is peeling in places and appears to exhibit the presence of mold.
4. Failure to provide adequate screening or other protection against pests [21 CFR 110.20(b)(7)]. For example, on July 24, 2012, flies too numerous to count were in the processing area, while the room windows were open. Window screens were torn, plastic strip curtains were in bad repair, and a door was partially open during food production.
5. Failure for anyone associated with the business to have completed the required HACCP training or to be HACCP qualified through job experience (21 CFR 123.10).
6. Failure to have properly installed and maintained plumbing and adequate floor drainage [21 CFR 110.37(b)(4)].
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 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 U.S.C. Parts 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.
FDA acknowledges the corrective actions you have voluntarily taken, such as signing your HACCP plan; cutting the grass; starting to clean processing equipment and facility; making structural repairs; and, obtaining signatures on the supplier guarantee.
We may take further action if you do not promptly correct all of the noted violations. For instance, legal actions may include product seizure or injunction. You should respond in writing within fifteen (15) working days from receipt of this letter. Your response should outline the specific steps you have taken to correct the noted violations. You should include in your response documentation such as HACCP and verification records, or other useful information to assist us in evaluating your correction. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the seafood HACCP regulations and the CGMP regulation. You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Kari L. Batey, Compliance Officer at the above address. If you have questions regarding any issues in this letter, please contact Ms. Batey at (615) 366-7808.
Patricia K. Schafer
New Orleans District