- Kettle Cuisine, LLC
- Issuing Office:
- New England District Office
| || |
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
CMS # 438793
UNITED PARCEL SERVICE
September 25, 2014
Mr. Joe Rainert
Chief Executive Officer
Kettle Cuisine, LLC
Lynn, MA 01901
Dear Mr. Rainert,
We inspected your seafood processing facility, located at 330 Lynnway, Lynn, MA, on July 22, 23, 29, 30, and August 5, 2014. Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, through links in FDA's home page at www.fda.gov.
We found that you have a serious violation 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, including cooked, refrigerated lobster bisque and cooked, refrigerated Manhattan clam chowder, both packaged in reduced oxygen retail cups, are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the
We acknowledge the receipt of your firm’s letter, dated August 21, 2014, in response to the form FDA 483, Inspectional Observations, issued during the inspection of your firm on August 5, 2014. We address this response below, in relation to the noted violation.
Your significant violation is 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for cooked, refrigerated lobster bisque and cooked, refrigerated Manhattan clam chowder, both packaged in reduced oxygen retail cups, entitled “Soups and Chowders” and dated May 7, 2014, does not list the food safety hazard of pathogenic bacteria introduction after cooking.
- On July 30, 2014, an FDA Investigator observed employees cut open underweight or defective finished product containers of Manhattan clam chowder and add them back into the holding tank during the filling process. The product is not further cooked after it is reintroduced into the holding tanks for filling. We acknowledge your firm’s response, which indicates your firm will no longer continue this practice.
- Additionally, we reviewed your firm’s response and conclude that it is not adequate. The response did not address our observation related to not identifying the food safety hazard of pathogenic bacteria introduction after cooking that is reasonably likely to occur at the hot filling, container sealing, and container cooling steps.
Please refer to Chapter 18 (Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes) of the Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, for guidance in determining the appropriate controls for your process.
We may take further action if you do not promptly correct this violation. 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 this violation. You should include in your response documentation such as copies of any revised HACCP plans, HACCP monitoring records to demonstrate that you have implemented the revised plans, any verification records, and other useful information, such as your firm’s hazard analysis if written, 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 the violation.
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.
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: Timothy M. Glod, One Montvale Avenue, Stoneham, MA 02180. Please reference the CMS number 438793 in your response.
If you have questions regarding any issues in this letter, please contact Mr. Glodat (781) 587-7473.
Mutahar S. Shamsi
New England District
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