| | |
 Department of Health and Human Services
| Public Health Service
Food and Drug Administration |
| | New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 587-7500 FAX: (781) 587-7556 |
WARNING LETTER
CMS # 247295
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
November 22, 2011
Ms. Mary Beal
Owner
H.R. Beals and Sons, Inc.
182 Clark Point Road
Southwest Harbor, ME 04679-4414
Dear Ms. Beal:
We inspected your seafood processing facility, located at 182 Clark Point Road, Southwest Harbor, ME on October 3, 2011 and October 28, 2011. 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 (RTE), refrigerated, vacuum packed lobstermeat is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 have a HACCP plan that at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for lobster meat lists a critical limit of (b)(4) at the (b)(4) critical control point that is not adequate to control pathogenic bacterial survival.
We acknowledge receipt of your response dated October 4, 2011 and found it unacceptable. Your proposed critical limit of (b)(4) monitoring technique is not based on nor has been evaluated by a scientific study. You must conduct a scientific study to validate that the (b)(4) that you have selected will provide an appropriate reduction in the numbers of the target pathogen (e.g., 6D) in the slowest heating unit or portion of product under the worst set of heating conditions covered by the scientific study. Your study must also demonstrate that the (b)(4) is the slowest heating portion of the product.
FDA recommends that if you intend to use (b)(4) as a critical limit you (1) conduct a temperature distribution study within the heating system to identify any cold spots; (2) conduct a heat penetration study that accounts for the slowest heating product under the worst case heating conditions covered by the scientific study; and identify other critical factors of processing and/or packaging that affect the rate of product heating when scientifically establishing a cooking or process (i.e., process validation). Those conditions may need to be identified as critical limits and monitored as part of the HACCP plan.
2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the safety of the water that comes into contact with food with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by:
In regards to the (b)(4) used during the RTE refrigerated vacuum packed lobstermeat manufacturing process for cooking raw lobsters and for cooling/chilling cooked lobsters prior to “picking” lobstermeat.
- No documentation is available to demonstrate that recommended manufacturing maintenance schedules are being implemented or followed for the (b)(4) system used to treat (b)(4) for microbiological contaminants.
- No documentation is available to demonstrate that the (b)(4) used during your lobstermeat manufacturing process is free of chemical, contaminants, or other pollutants.
We acknowledge receipt of your response dated October 4, 2011. We understand that you will be following the manufacturer’s recommendations for maintaining your (b)(4) system. In your response please provide us with documentation demonstrating you implemented and are adhering to the recommended manufacturer’s maintenance schedules. We also understand you will be purchasing additional filters to ensure the (b)(4) is free of chemical, particles or other pollutants prior to your 2012 “picking season”. Please provide us with the detailed information and specifications on the filters once they have been installed.
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. Failure to promptly correct these violations may result in legal action without further notice including, but not limited to, seizure and injunction.
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.
Please send your reply to the Food and Drug Administration, Attention: Lori A. Holmquist, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine 40330. If you have questions regarding any issues in this letter, please contact Ms. Holmquist at 207.622.8268 x 13.
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District Office
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