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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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James McCanna 07-Apr-05

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

April 7, 2005






James R. McCanna, Co-owner
James McCanna
dba East Bay Crab & Lobster
45 Cutler Street
Warren, Rhode Island 02885

Dear Mr. McCanna:

On December 7, 15, 16 and 23, 2004, we inspected your seafsood processing facility, located in Warren, Rhode Island. We found that you have serious deviations from the seafood Hazard Analysis Critical Control Points (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 to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the 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 cooked ready-to-eat Jonah crabmeat is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You may find this Act, the seafood HACCP regulation and FDA's Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.

The deviations were as follows:

1. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for [redacted] crabmeat lists monitoring procedures that are not adequate to control pathogens. For exarnple:

a. At the cooking critical control point, your HACCP plan ,state procedure of [redacted]. That monitoring procedure is not adequate to control pathogen growth in each unit of crab to represent the entire batch of cooked crabs. Monitoring the [redacted] from the entire batch will not ensure that all crab sections in the batch receive an adequate cook. This is because there can be cooler as well as warmer spots in the cooker, and there is no way to know whether this [redacted] is in fact, representative of the other crab sections in the cooker. As an alternative to monitoring internal temperature, and to ensure that there is no variability in the cook process applied to [redacted] or piece, the Hazard Guide suggests monitoring a cook time coupled with a cook temperature (i.e., temperature of the cooking water) using a recording device that continuously monitors time and temperature for the duration of the cooking process. Where cooking is performed at the boiling point, visual observation of minutes at a boil may also be an acceptable alternative.

b . At the refrigerated storage critical control point, your HACCP plan states a monitoring procedure of [redacted]. That monitoring procedure is not adequate to control pathogens and is not effective for implementing your corrective action. As the corrective action at your storage critical control point, your plan states that product will be [redacted]. However monitoring the cooler temperature only [redacted] will not ensure that fluctuations in temperatures above [redacted] have not occurred for more than [redacted] thus exceeding your critical time limit for taking a corrective action. To ensure that proper temperatures are maintained during refrigerated storage, the Hazard Guide recommends the use of continuous temperature monitoring devices in your cooler, with a visual check of the equipment once per day.

For more information on the hazards associated with pathogen growth in cooked ready to eat crab meat products, please refer to Chapters 12, 16 and 17 of the Hazard Guide.

2. You must adequately monitor sanitation conditions and practices during processing to comply with 21 CFR 123.11 (b). However, your firm did not monitor these sanitation conditions accurately. For example, you recorded the safety of the water as satisfactory, yet a hose was observed submerged in your cooling vat that had no backflow prevention device. Furthermore, you recorded the prevention of cross contamination with unsanitary objects and the cleanliness of food contact surfaces as satisfactory, yet finished products were observed in wire mesh containers, exposed while placed on the floor. Also, your cooling vats were observed to be unclean.

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.

Please respond in writing within fifteen (15) days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation, such as a completed HACCP plan, or other useful information, that would assist in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation and the 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, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. Ota at (781) 596-7762.


Gail T. Costello
District Director
New England District