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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Clem's Seafood & Specialities, Inc. 20-Sep-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771


September 20, 2005

Harmon Clem, Jr., President
Clem's Seafood & Specialties, Inc.
4505 Mattingly Road
Buckner, KY 40010-8830


Dear Mr. Clem:

We inspected your firm, located at the above address on June 24, 2005. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 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 that 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 U.S.C. 342(a)(4). Accordingly, your oyster products are adulterated in that 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 in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. You must have a HACCP plan that at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard. However your firm's HACCP plan for oysters lists a critical limit, "Certificate accompanying all lots received indicates that the oysters were not harvested from waters that were so contaminated by chemical as to make it reasonably likely that the levels in the oyster meat would be in excess of established tolerances, action levels or guidance level" at the "Receiving" CCP that is inadequate to control the hazards of pathogens and natural toxins. FDA recommends that your firm monitor the various molluscan shellfish products you receive for the presence of either tags or labels that provide the necessary information required by the shellfish control authority. In addition, all finished product shellstock intended for raw consumption must bear a tag that instructs retailers to inform their customers that consuming raw or undercooked shellfish may increase the risk of foodborne illness, especially for individuals with certain medical conditions.

All molluscan shellfish must be from a harvester that is licensed as required (note that licensing may not be required in all jurisdictions) or from a processor that is certified by a shellfish control authority.

Tags that are affixed to all shellstock (in-shell molluscan shellfish) containers should list the date and place they were harvested (by State and site), type and quantity of shellfish, and by whom they were harvested (i.e., the identification number assigned to the harvester by the shellfish control authority, where applicable or, if such identification numbers are not assigned, the name of the harvester or the name or registration number of the harvester's vessel). For bulk shipments of shellstock, where the shellstock is not containerized, accept shellstock only if it is accompanied by a bill of lading or other similar shipping document that contains the same information. Your monitoring activities should assure that the tags and necessary information are present.

Labels that should be affixed to all containers of shucked molluscan shellfish should identify the name, address, and certification number of the packer or re-packer of the product. Again, your monitoring activities should assure that this information is present.

2. You must have a HACCP plan, that at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your HACCP plan for oysters lists a monitoring frequency of "One a day at start-up" at the "Storage in Cooler" critical control point that is not adequate to control for pathogens. FDA recommends either continuous monitoring of storage temperature or periodic checking of the adequacy of a coolant such as ice to control pathogen growth during the storage of products that will be consumed without additional cooking.

3. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm does not monitor employee health conditions and the labeling, storage and use of toxic compounds as evidenced by the fact that your master sanitation schedule does not list either of these categories.

These three observations had been listed on a FDA-483 that was issued in June, 2004 and addressed in a letter that we sent to you dated January 25, 2005. You have not yet taken any action to correct these items.

We may take further action if you do not promptly correct these violations. For instance, we may take action to seize your product(s) and/or enjoin your firm from operating.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us 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.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 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.

Please send your reply to the Food and Drug Administration, Cincinnati District Office, 6751 Steger Drive, Cincinnati, OH 45327-3097 Attention: Attention: Stephen J. Rabe, Compliance Officer.



Carol A. Heppe,
Director Cincinnati District