Inspections, Compliance, Enforcement, and Criminal Investigations
Ipswich Shellfish Co., Inc. 10/19/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District Office|
One Montvale Avenue, 4th floor
Stoneham, MA 02180
UNITED PARCEL SERVICE
October 19, 2012
Ms. Chrissi Papas
Ipswich Shellfish Co., Inc.
8 Hayward Street
Ipswich, MA 01938
Dear Ms Papas:
We inspected your seafood processing and importer establishment, located at 8 Hayward Street, Ipswich, MA on September 11, 2012 to September 21, 2012. 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 Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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).
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4).
Accordingly, your imported live lobsters; ready-to-eat cooked lobstermeat; vacuum packed smoked salmon; and raw scallops and raw trout fillets in reduced oxygen packaging 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 domestic violations were as follows:
- 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 and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and 21 CFR 123.6(b). However, you do not have HACCP plans for refrigerated raw sea scallops in press-lid cans or raw refrigerated trout fillets in plastic filmed containers to control the hazard of Clostridium botulinum toxin formation.
- 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." Specifically,
- Your firm’s HACCP plan for cooked ready-to-eat lobstermeat lists a cooking critical limit of (b)(4) which is not adequate to control pathogenic bacterial survival. Your proposed critical limit of (b)(4) monitoring technique is not based on nor has been evaluated by a scientific study.
- Your firm’s HACCP plan for cooked ready-to-eat lobstermeat lists a critical limit of (b)(4) at the cooling CCP, which is not adequate to control pathogenic bacterial survival.
- 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 firm’s HACCP plan for Reduced Oxygen Packaged Seafood lists a monitoring procedure/frequency of (b)(4) receiving CCP which is not adequate to control Clostridium botulinum toxin formation and pathogen growth for your firm’s refrigerated ready-to-eat smoked salmon product. Currently (b)(4) per shipment is recorded upon receipt.
- You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, you are not implementing the monitoring procedure of (b)(4) receiving CCP to control Clostridium botulinum toxin formation and pathogen formation. Specifically, smoked salmon products are received in company owned vehicles not equipped with continuous temperature monitoring and are not received with ice or cooling media.
- You failed to store and dispose of rubbish and any offal to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces in accordance with 21 CFR 110.37(f). Specifically, crates used to handle lobsters were used as trash receptacles and excessive trash was observed in the live lobster area.
- 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 did not monitor the prevention of cross-contamination from insanitary objects to food, food packaging materials or protection of food, food packaging material, and food contact surfaces from adulteration with other food contact surfaces with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
- Raw materials were observed directly stored on the floor in the receiving area, finished product cooler, fish processing cooler, and freezer.
- Open, exposed bags, containers, and food packaging material were observed in the freezer and the dry storage area.
Your significant import violation is as follows:
- You are not implementing the affirmative step for the fishery products you import in accordance with the seafood HACCP regulation, 21 CFR 123.12(a)(2)(ii).
We acknowledge receipt of an email response dated 9/14/2012 which provided us with product specifications and a written guarantee of a recent shipment of live lobsters from your supplier. However, during the inspection and in this email response, you did not provide us with documentation that periodic testing has been conducted on your imported fishery products.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
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 importer verification records, records that document the performance and results of your firm’s affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 seafood importer establishment operates in compliance with the Act and 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 for your fish or fishery products, including those that you import into the United States.
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 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.
Please send your reply to the Food and Drug Administration, Attention: Ms. Lori A. Holmquist, Compliance Officer, 330 Civic Center Drive, Suite 1, Box 4, Augusta, ME 04330. If you have questions regarding any issues in this letter, please contact Ms. Holmquist at 207.622.8268 x 13.
Mutahar S. Shamsi
New England District Office
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