- Goff Seafood
- 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
June 19, 2017
Warning Letter 526986
Herbert A. Goff
735 Magnolia Park Road
Dry Prong, LA 71423-3611
Dear Mr. Goff:
The Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility located at 735 Magnolia Park Road, Dry Prong, Louisiana, from May 22 through May 25, 2017. During the inspection, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations (21 CFR), Part 110.
At the conclusion of the inspection FDA issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your facility at the time of the inspection. Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR Part 110 renders your firm’s food products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 United States Code Section 342(a)(4), in that they have been 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. You can find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
We acknowledge the receipt of your letter dated June 13, 2017 in which you provided a response to each of the FDA’s concerns. Our comments concerning your response are noted below.
Your significant violations under section 402(a)(4) of the Act are:
1. Your firm failed to provide sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1). Specifically, our investigators observed at least 10 (b)(4) freezers stored outside under a pole barn style storage facility. This pole barn style storage facility did not have walls, and was exposed to the elements. During the inspection, rain water was observed leaking from the roof, as well as being blown into the storage area and accumulating onto freezers containing product.
In your response you state that you will enclose the storage area for these freezers within three months. Please provide an update to this response and include facility drawings or blueprints and include a description of the type of material(s) out of which the structure will be constructed.
2. Your firm failed to provide adequate and readily accessible toilet facilities maintained in a sanitary condition as required by 21 CFR 110.37(d)(1). Specifically our investigators observed that you used an outhouse with apparent fecal matter in the toilet bowl.
You indicate that you will clean the restroom on a routine basis. Photographs of the cleaned facilities would enable us to better evaluate your corrective action.
3. Your firm failed to provide adequate and convenient hand-washing facilities as required by 21 CFR 110.37(e). Specifically our investigators noted that your outhouse did not have a hand-washing station.
You state that you will install a handwashing station. Once the installation is complete, please provide additional documentation such as photographs to demonstrate that this is corrected.
4. Your (b)(4) freezers used to store raw frozen shrimp were not fitted with an indicating thermometer, temperature-measuring device or temperature-recording device so installed as to show the temperature accurately within the compartment as required by 21 CFR 110.40(e).
We note that you have ordered (b)(4) for each freezer. You should provide evidence of this corrective action such as a copy of a purchase order or other documentation that you purchased the items.
5. Your firm failed to clean food-contact surfaces as frequently as necessary to protect against contamination of food as required by 21 CFR 110.35(d). Specifically, our investigators observed a gross accumulation of apparent shrimp shells from previous processing days on the stainless steel table and scale located inside the processing room and apparent shrimp shells were accumulating inside all four compartments of the stainless steel sink located inside the processing room.
We acknowledge that you are now cleaning the packaging plant. This will be verified during a future inspection of your firm.
6. Your (b)(4) freezers were not properly maintained as required by 21 CFR 110.40(a). Specifically, our investigators observed:
- The exterior and interior of the (b)(4) freezers containing bulk and finished product had exposed rust and chipping paint.
- No fewer than 8 of the (b)(4) freezers had exposed insulation.
- No fewer than 5 of the (b)(4) freezers lids did not fit securely.
- A beetle type insect was observed in the exposed insulation of one (b)(4) freezer located under the pole barn style storage facility.
We note that you are cleaning and repairing the freezers. Please provide evidence such as repair records, photographs or other evidence that the freezers are repaired.
7. Your firm’s plumbing was not of adequate design and adequately installed and maintained to provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing as required by 21 CFR 110.37(a)(5). Specifically, our investigators observed a hose used to rinse the exterior (b)(4) freezers was stored directly on the floor (outside) with no means of back flow prevention.
In your letter, you promise to install a new hose rack and back-flow prevention device. You should provide documentation such as photographs when this action is complete.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action such as seizure or injunction, without further notice.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Please respond to this office in writing within 15 working days from your receipt of this letter. In your response, identify the procedures you have taken or will take to completely correct the current violations and prevent similar ones. Please include an update and documentation of your corrective actions as noted above. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the timeframe in which you will complete the corrections.
Send your reply to Stephen J. Rabe, Compliance Officer at the address listed in the letterhead. If you have questions regarding any issue in this letter, please contact Mr. Rabe at 513-679-2700 extension 2163 or Stephen.firstname.lastname@example.org.
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations - East