Inspections, Compliance, Enforcement, and Criminal Investigations
Boston Salads & Provisions Co., Inc. 07-Sep-06
Department of Health and Human Services
Public Health Service
New England District
RETURN RECEIPT REQUESTED
September 7, 2006
John Zofchak, President
Boston Salads & Provisions Co., Inc.
85 Newmarket Square
Boston, MA 02118
Dear Mr. Zofchak:
We inspected your seafood processing facility, located at 85 Newmarket Square, Boston, Massachusetts on July 10 to 14 and August 4, 2006. 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(ax4). Accordingly, your seafood salad and refrigerated clam chowder 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 conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). However your firm does not have a HACCP plan for the receipt and storage of New England Clam Chowder packed in hermetically sealed bags to control the food safety hazard of pathogens, specifically Clostridium botulinum.
2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and(c) (2). A critical control point is defined in 21 CFR Part 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for seafood salad does not list the critical control point of "Thawing" (i.e., of the frozen modified atmosphere packaged surimi) for controlling the food safety hazard(s) of Clostridium botulinum growth and toxin formation.
3. 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 Seafood Salad and Seafood Salad Delight lists a monitoring procedure at the "Cooler Storage" critical control point that is not adequate to control pathogens. Intermittent temperature checks (i.e., 3 times per shift) do not ensure that temperatures are adequately monitored 24 hours a day, seven days a week including those times when you are not operating and thus there are no personnel on shifts to perform the checks. In lieu of intermittent temperature checks at storage, FDA recommends implementing a method of continuously monitoring the temperatures, such a continuous recording device with a daily check of the temperature readings and the equipment.
We are in receipt of your July 21, 2006 response to the FDA-483 issued to your firm on July 14, 2006, wherein you described the actions you were taking to correct the 483 items issued at the conclusion of the inspection. For example, you committed to begin using a Dickson continuous data logger within 't4 days of the inspection. However, a follow-up inspection and discussion conducted on August 4, 2006 revealed that you still had not implemented any of the described corrections.
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 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: Bruce R. Ota, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. Ota at 781-596-7762.
Gail T. Costello