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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Dennis Paper and Food Service 6/15/2009

 

 

   

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, MA 02180
(781) 596-7700
FAX: (781) 596-7896

WARNING LETTER

NWE-12-09W

VIA Federal Express


June 15, 2009


Ron Dennis, President
Dennis Paper and Food Service
101 Mecaw Road
Hampden, Maine 04401

Dear Mr. Dennis:

We inspected your seafood processing facility, located on 101 Mecaw Road, Hampden, Maine, on January 7, 8, 14 and March 9, 2009. 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). 1n 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. ยง 342(a)(4). Accordingly, your seafood salad and refrigerated pasteurized crabmeat are 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.

Your significant violations were as follows:

1. You must implement the monitoring and record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, from 6/23/2008 to 12/25/2008, 33 shipments of seafood salad were received from (b)(4) and none of your data logger files were reviewed at receiving as required by your HACCP plan. Further, of the 33 shipments only 6 of the data logger files could be downloaded and viewed.

2. 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 fresh cooked crab and refrigerated pasteurized crabmeat lists a monitoring procedure and frequency at the receiving critical control point that is not adequate to control pathogen growth and toxin formation. Your HACCP plan lists a monitoring procedure (b)(4) with a frequency of (b)(4) that are not adequate to ensure temperature control during transit and prior to your receipt. Your monitoring procedure and frequency should include continuous monitoring of refrigeration temperature, such as a truck data logger, during transit that may be reviewed upon your receipt of product.

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 facility operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), and the Current Good Manufacturing Practice regulation (2.1 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.

 


Sincerely,

 


John Marzill
District Director
New England District
....