| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human Services
May 13, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 22
Lin Tep
Owner
Import Food Wholesale
865 Pierce Butler Route
St. Paul, Minnesota 55104
Dear Mr. Tep:
We inspected your seafood processing facility located at 865 Pierce Butler Route, St. Paul, Minnesota, on November 18 - November 24, 2010. 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 and 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 smoked uneviscerated fish 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 on FDA's home page at www.fda.gov.
Your significant violation is as follows:
1. You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a). However, your firm has not performed a hazard analysis for smoked uneviscerated fish to control the food safety hazard of Clostridium botulinum. FDA considers uneviscerated fish over 5 inches that have been salt-cured, dried, or smoked, as well as products made from them, to be adulterated. A hazard analysis would show that your firm should not accept or receive uneviscerated large fish, which are inherently unsafe whether stored at ambient temperature, refrigerated, or frozen, and whether packaged in air, vacuum, or modified atmosphere.
Please note that any seafood products you could potentially receive and hold for distribution must have a hazard analysis conducted to determine whether there are food safety hazards that are reasonably likely to occur and, if necessary, have and implement a written HACCP plan for those fishery products to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b).
We also determined that your facility is subject to the registration requirement in § 415 of the Act, 21 U.S.C. § 350d, and our implementing regulation at 21 CFR Part 1, Subpart H. During our inspection referenced above, your representative was advised of this requirement. The failure to register a facility as required is a prohibited act under § 301 of the Act, 21 U.S.C. § 331(dd). Our records indicate that, to date, this facility has not been registered with FDA.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility's owner, operator, or agent in charge, register the facility with FDA within 15 working days of the date of this letter. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by this facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to 301-210-0247 or mailed to the address above. FDA will process registration submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance (the Hazard Guide), third edition, through links on FDA's home page at www.fda.gov.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
You should respond in writing within 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 123) and the Current Good Manufacturing Practice regulation (21 CFR 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 Compliance Officer Rebecca L. Caulfield at the address on this letter. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612)758-7194.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
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