Fells Point Wholesale Meats, Inc. 2/24/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
February 24, 2012
Return Receipt Requested
Erik M. Oosterwijk, President
Fells Point Wholesale Meats, Inc.
2730 Wilmarco Avenue
Baltimore, MD 21223
Dear Mr. Oosterwijk:
We inspected your pet food manufacturing and seafood warehouse facility, located at 2730 Wilmarco Avenue, Baltimore, MD on December 5, 6 and 8, 2011. 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 (21 CFR 123). 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 seafood products are adulterated, as 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 current edition of 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 conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product you process to determine whether there are food safety hazards which are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards which are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have HACCP plans for your seafood products, for example pasteurized swimming crabmeat, vacuum-packed smoked salmon and pickled herring, to control the food safety hazards of pathogen growth and toxin formation from time/temperature abuse.
2.) You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with Current Good Manufacturing Practice (CGMP) requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not appropriately monitor the maintenance of hand washing facilities, the proper labeling, storage and use of toxic compounds, and the control of employee health conditions, as well as accurately document conditions and practices at your firm as evidenced by the following observations made by our FDA Investigator during our inspection:
a.) Apparent pieces of meat, fat, and dried blood were observed adhering to the inner surface of the hand washing sink in the men’s bathroom.
b.) Sanitation and monitoring records do not include observations of proper labeling, storage and use of toxic compounds.
c.) The sanitation and monitoring record for control of employee health conditions was observed to be inadequate in that employees were not appropriately scrutinized or questioned.
d.) An approximately seven foot by four foot area of apparent meat, fat and dried blood on the floor of the freezer was not noted during operational sanitation monitoring.
We may take further action if you do not promptly correct these violations. For instance, we may take further 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 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 the U.S. Food and Drug Administration, Attention: Ernest F. Bizjak, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Bizjak at (410) 779-5715.
Baltimore District Office