Inspections, Compliance, Enforcement, and Criminal Investigations
Foods Galore Inc 18-Oct-05
Department of Health and Human Services
Public Health Service
Telephone (973) 526-6008
RETURN RECEIPT REQUESTED
October 18, 2005
File # 06-NWJ-03
Mr. Mort Waxler
Foods Galore, Inc.
9246 Commerce Highway
Pennsauken, NJ 08110
Dear Mr. Waxler:
We inspected your seafood processing facility, located at 9245 Commerce Highway, Pennsauken, New Jersey on August 8 and 10, 2005. 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) seafood salads and vacuum-packed smoked fish products 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 were as follows:
You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control Clostridium botulinum toxin formation and pathogen growth, when your process for storing refrigerated, ready-to-eat seafood products deviated from your critical limit at the storage critical control point. Specifically, you did not take a corrective action when your storage cooler temperatures exceeded your critical limit of "36 degrees." A review of your monitoring records revealed that on July 25, 26, 27, 28, 29 and August 2, 3, 5, and 8, 2005, temperatures in the three walk-in refrigerator units in which you store ready-to-eat seafood products, ranged from 42 to 50 ° F, for periods of at least 8 hours.
You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123 .6(c)(4). However, your firm's HACCP plan for "All Fish/Seafood/Salad Products" lists a monitoring procedure at the Receiving critical control point that is not adequate to control the food safety hazards of "bacteria and C. botulism," that you identified for this plan that covers readyt to-eat products such as seafood salads and vacuum packaged smoked fish;, and the food safety hazard of scombrotoxin formation that can occur in your tuna products, such as tuna salad. Specifically, your current procedure of monitoring the ambient air temperature of the delivery vehicle at receipt does not ensure that products were held at appropriate temperatures to prevent time/temperature abuse for your high-risk, ready-to-eat, seafood products, during transit to your facility. Moreover, a continuous temperature monitoring method is recommended for products that are in transit for extended time periods (i.e., greater than 4 hours).
You must retain records required under 21 CFR Part 123 at the processing facility for at least 1 year after the date they were prepared in the case of refrigerated products and for at least 2 years after the date they were prepared in the case of frozen, preserved, or shelf stable products, to comply with 21 CFR 123.9(b)(1). However, your firm's daily monitoring records for the receipt and storage of refrigerated, ready-to-eat seafood products were only retained from July 22, 2005 to August 10, 2005. None of your HACCP monitoring records prior to July 22, 2005 were available for review.
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: Richard Manney, Compliance Officer, at U.S. Food and Drug Administration, 10 Waterview Boulevard, Parsippany, New Jersey. If you have questions regarding any issues in this letter, please contact Mr. Manney at (973) 526-6008.
Douglas I. Ellsworth
New Jersey District