| Public Health Service Food and Drug Administration |
| New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 596-7700 FAX: (781) 596-7896 |
Department of Health and Human Services
WARNING LETTER
NWE-12-10W
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
January 13, 2010
Mr. Richard Cohen, CEO
C & S Wholesale Grocers, Inc.
7 Corporate Drive
Keene, NH 03431
Dear Mr. Cohen:
We inspected your seafood processing facility, located on 95 North Hatfield Road, Hatfield, MA 01038-9773 on August 27, 2009, August 31, 2009, September 3, 2009, and September 8, 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). 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, ready to eat, pasteurized canned crabmeat 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 are as follows:
1. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan to comply with 21 CFR 123.6 (b) and (c)(4). However your firm did not follow the monitoring frequency of product temperature taken with each seafood delivery or (b)(4) check of the temperature monitoring device at the receiving critical control point to control the hazard of Clostridium botulinum growth and toxin formation for refrigerated, ready-to-eat, pasteurized canned crabmeat. Specifically, between January 6, 2009 and August 28, 2009, your firm received (b)(4) shipments of the pasteurized crabmeat, but in eight instances the shipment temperatures were not monitored.
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 revised HACCP plan for refrigerated, ready-to-eat, pasteurized canned crabmeat lists a monitoring frequency at the receiving critical control point that is not adequate to control the hazard of pathogens, including Clostridium botulinum growth and toxin formation, associated with refrigerated pasteurized crabmeat, hot smoked salmon, and surimi. Your plan lists that you will "(b)(4) check for TMDâ€, but does not state that you will review the record. In addition, your plan allows for product temperatures to be monitored when cooling media or a temperature monitoring device is not present. Product temperatures do not provide an adequate safety assurance of transportation conditions when products have been transported for extended periods (e.g. greater than (b)(4)). We also note that your plan does not list that you will maintain a copy of the time/temperature chart or log as part of your monitoring records.
Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
We are in receipt of your letter of September 18, 2009 responding to the List of Inspectional Observations, FDA Form 483, issued on September 8, 2009 at the conclusion of the inspection.
The corrective actions which you propose do not adequately address the following concern raised by the FDA 483, in that:
• You provided no documentation on the type of temperature monitoring devices that are installed on the carriers.
• You provided no data generated by the instruments to show they were installed and working properly.
• You provided no evidence that personnel are now appropriately monitoring the temperature of seafood products upon receipt.
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.
Please send your reply to the Food and Drug Administration, Attention: Attention: Lori A. Holmquist, Compliance Officer, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine 04330. If you have questions regarding any issues in this letter, please contact Ms. Holmquist at 207.622.8268 x 13.
Sincerely,
/s/
John R. Marzilli
District Director
New England District
cc: Mr. Matt D. Hettinger
95 N Hatfield Rd
Hatfield, MA 01038-9773
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