Inspections, Compliance, Enforcement, and Criminal Investigations
Clark Seafood Co, Inc 6/24/13
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
June 24, 2013
WARNING LETTER NO. 2013-NOL-13
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Philip J. Horn, President
Clark Seafood Company, Inc.
4401 Clark Street
Pascagoula, Mississippi 39567
Dear Mr. Horn:
On April 10-12, 2013, an investigator with the U.S. Food and Drug Administration (FDA), inspected your seafood processing, packing, and warehouse facility located, at 4401 Clark Street, Pascagoula, Mississippi. The inspection found significant deviations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), and 21 CFR 110, Current Good Manufacturing Practices (CGMP) for human food. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan which complies with this section or otherwise operate in accordance with the requirements of Part 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), 21 USC 342(a)(4).
Accordingly, all of your seafood products are adulterated because they have been prepared, packed, or held under insanitary condition 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 in FDA’s Internet home page at www.fda.gov.
We acknowledge the receipt of your letter dated May 7, 2013, responding to the FDA 483, Inspectional Observations (FDA 483), issued to you on April 12, 2013. This letter will become a part of our official files. Your response is inadequate because you have not implemented corrective actions or provided any substantive proof of the corrective actions to be taken at your facility. The deviations listed on the FDA 483 include the following:
1. Failure to have a written HACCP plan which outlines controls for a food safety hazard which is reasonably likely to occur [21 CFR 123.6(b)]. There is no written HACCP plan for fresh fish (Amberjack) to control the hazard of scombroid toxin formation due to time/temperature abuse. There are no controls in place for the receipt and storage of this product as evidenced by: you do not monitor or have records to show the product was not temperature abused during transit and you do not have cooler or freezer monitoring records or continuous monitoring of the temperature in your walk in cooler where the product is stored.
2. Failure to monitor the sanitation conditions and practices with sufficient frequency to assure conformance with CGMP including safety of water which comes into contact with food or food contact surfaces, including water used to manufacture ice [21 CFR 123.11(b)]. No well water testing is performed.
3. Failure for an employee of your firm to have completed the required HACCP training or is HACCP qualified through job experience (21 CFR 123.10).
4. Failure to maintain sanitation control records which document monitoring and corrections of sanitation deficiencies for safety of water which comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, and sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions, and exclusion of pests [21 CFR 123.11(c)].
5. Failure to 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)].
6. Failure to have adequate drainage of areas which may contribute to contamination of food by seepage and providing a breeding place for pests [21 CFR 110.20(a)(3)].
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 and all applicable regulations, including the seafood HACCP regulation (21 CFR Par 123) and the Current good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. FDA may take further action if you do not promptly correct these violations, including product seizure and or injunction of your firm from operating.
The FDA has determined that your facility is subject to the registration requirement in Part 415 of the Act [21 USC 350d], and our implementing regulation at 21 CFR Part 1, Subpart H. During the April 10-12, 2013 inspection, you were advised of this requirement. The failure to register a facility as required is a prohibited act under Part 301(dd). Our records indicate that, to date, this facility has not been registered with FDA. As a responsible official of a facility which manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring your overall operation and the products you distribute are in compliance with the law. We request that you or an individual you authorize to register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at www.fda.gov, under the Food Registration heading. We strongly encourage the use of electronic registration, but alternatively, you may request the Form 3537 by calling the FDA Industry systems Help Desk at 1-800-216-7331. When completed, the form may be faxed to (301) 210-0247.
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 which 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 evaluation the results of the re-inspection and assessing and collecting the re-inspection fees [21 USC 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.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific thing you are doing to correct these violations. You should include in your response documentation such as copies of any HACCP plans, at least five (5) production days worth of HACCP monitoring records to demonstrate you have implemented the monitoring operations, any verification records and other useful information which would assist our office in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your response should be directed to Kari L. Batey, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. You may also contact Ms. Batey at (615) 366 7808.
Patricia K. Schafer
New Orleans District