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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Portland Shellfish Company, Inc. 1/15/09


Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896



January 15, 2009

Jeffrey Holden
Portland Shellfish Company, Inc.
92 Waldron Way
South Portland, ME 04103

Dear Mr. Holden:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 92 Waldron Way, South Portland, ME on October 20 through November 4, 2008. 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 ready-to-eat cooked lobstermeat products 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 violations are as follows:

1. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6(c)(4). However your firm°s revised HACCP plan for cooked ready-to-eat lobster meat does not list monitoring procedures at the cooking critical control point that are sufficient to monitor the cooking steps.

For example, the batch cooking step and continuous cooking step list a critical limit of achieving an internal product temperature of [(b)(4)] and your corrective action plan is based on this critical limit. The monitoring procedures for each of these steps fail to indicate how you plan to monitor your internal temperature critical limit. FDA recommends that you implement monitoring procedures based on a study of your cooking process. For example, a process study would help you determine the parameters for conducting the internal product temperature monitoring, such as the sampling size and the product location in the cooker.

Also, the monitoring procedures listed for your continuous cooking CCP are not adequate. The critical limit for this step specifies that product is cooked for [(b)(4)]. However, your monitoring step indicates that you are looking at the belt speed setting. The monitoring steps should correlate directly with the critical limit. For instance, if your firm uses some type of belt speed/cook time conversion chart, this chart should be referenced in your plan.

Also, your HACCP plan at the cooler storage CCP states that temperature of the cooler should be checked twice daily to ensure that the temperature does not exceed your critical limit of [(b)(4)]. FDA recommends that you use an instrument to continuously monitor ambient temperature, with a visual check of the record once per day. Alternatively, if you store these products under ice or other cooling media, FDA recommends that you monitor the adequacy of the cooling media at least twice per day. If you choose to use a temperature alarm, then you would need to include steps to assure that the alarm is working properly every day.

2. Because you chose to include a corrective action plan in your HACCP plan, your described, corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for ready-to-eat lobster meat at the critical control point of batch cooking does not include appropriate corrective actions for temperature deviations such as, investigating the cause of the critical limit deviation, and measures taken to prevent the recurrence of the deviation.

We may take further action if you do not promptly correct these above violations. 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.

The above is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the Act and federal regulations.

Please send your reply to the Food and Drug Administration, Attention: Karen N. Archdeacon, Compliance Officer, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Ms. Archdeacon at 781-596-7707.



John R. Marzilli
Acting District Director
New England District