Inspections, Compliance, Enforcement, and Criminal Investigations
Portsmouth Chowder Co. 9/12/13
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 # 411201
UNITED PARCEL SERVICE
September 12, 2013
Robert R. Lincoln
Portsmouth Chowder Company
124 Heritage Ave, Unit 1
Portsmouth, NH 03801-5645
Dear Mr. Lincoln:
We inspected your seafood processing facility, located at 124 Heritage Ave, Unit 1 Portsmouth, NH 03801-5645 on July 17 through August 2, 2013. 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 & 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 refrigerated and frozen clam chowder is adulterated, in that it has 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.
Specific violations observed during the inspection include, but are not limited to, the following:
1. 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 clam chowder lists monitoring procedures and frequencies at the cook step-lethality (pathogen control) critical control point that do not ensure that the hazards C. botulinum and pathogenic formation are controlled for at this critical control point (CCP).
We have received your revised HACCP plan in your August 20, 2013 response to the FDA 483 issued at the close of the inspection. The revised HACCP plan states your firm will have an employee (b)(4) monitor the time-temperature reached and held at or above (b)(4) Fahrenheit for each pasteurized batch of product cooked in each steam kettle prior to release of the product for bagging and an employee visually monitor the temperature of the product near the end of the filling process. This is not adequate to ensure in process product is continuously maintained at specified temperatures. A continuous temperature recording device should be utilized to ensure that the critical limits that are established by a scientific study during pasteurization have been met. This is a repeat observation from the previous inspection.
For information concerning the hazards of pathogens and Clostridium botulinum toxin formation please refer to Chapters 12, 13 and 16 of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition.
During the December 11, 2012-January 3, 2013 inspection close-out discussion you stated that you would work towards performing a complete temperature distribution study for both (b)(4) steam kettles. You also stated, based on that study, you would install continuous temperature-recording devices with probes in the coldest location of the steam kettles to monitor the pasteurization cycle. Furthermore, you said that you would have to consult with the supplier of the continuous filler machine to identify a location where a continuous temperature monitoring device probe could be installed to measure the hot fill temperatures. This information was not provided during the most recent inspection or in your response to the FDA 483.
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 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: Diane M. Prince, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Ms. Prince at 781-587-7442.
Joseph Matrisciano Jr.
Acting District Director
New England District Office