|Company:||Ipswich Shellfish Co., Inc.|
|Subject:||Seafood HACCP/CGMP for Foods/Adulterated|
|Issuer:||New England District Office|
|Issued:||June 11, 2008||Closed:||
Department of Health and Human Services
Public Health Service
New England District
June 11, 2008
Via Certified Mail
Chris Pappas, Owner
Ipswich Shellfish Co., Inc.
8 Hayward Street
Ipswich, Massachusetts 01938
Dear Ms. Pappas:
We inspected your seafood processing facility, located at 26 East Industrial Road, Branford, Connecticut on May 19, 20 and 22, 2008. 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, 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 mahi mahi, tuna and pasteurized crabmeat 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 violation is as follows:
• You must implement the record keeping system that you list in your HACCP plans, to comply with 21 CFR 123.6 (b) and (c)(7). However, on at least [redacted] occasions over the past [redacted] your firm did not record temperature monitoring observations at the receiving critical control point for your histamine producing seafood products or your pasteurized crabmeat.
We may take further action if you do not promptly correct this violation. For instance, we may take further action to seize your product 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, Attention: Bruce R. Ota, Compliance Officer, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. Ota at 781-596-7762
Michael R. Kravchuk
Acting District Director
New England District
cc: Kevin P. Cove, General Manager
Connecticut Shellfish Co.
26 East Industrial Road
Branford, Connecticut 06405