Inspections, Compliance, Enforcement, and Criminal Investigations
Bobby Chez, Inc. 10-Nov-05
Department of Health and Human Services
Public Health Service
New Jersey District
RETURN RECEIPT REQUESTED
November 10, 2005
Mr. Robert Sliwowski
Bobby Chez, Inc.
Village Walk, 1990 Route 70 East
Cherry Hill, New Jersey 08034
Dear Mr. Sliwowski:
We inspected your seafood processing facility, located at Village Walk, 1990 Route 70 East, Cherry Hill, New Jersey on September 21, 22, and 27, 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 crab cakes, lobster mashed potatoes, and ready-to- eat (RTE) seafood salad 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 conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and have written HACCP plan(s) to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm does not have HACCP plan(s) for the manufacture of crab cakes, lobster mashed potatoes, and seafood salad (an RTE food), to control the potential food safety hazards of Clostridium botulinum, Staphylococcus aureus, and Bacillus cereus growth and toxin formation.
You must adequately monitor sanitation conditions and practices at your firm and take appropriate corrective actions when warranted, in order to comply with 21 CFR 123.11(b). However, your firm does not maintain sanitation monitoring records for the sanitation control points (SCPs) applicable to your firm. Further, during the current inspection, our investigators observed actual sanitation deficiencies at the following key sanitation control points:
(a) Prevention of cross-contamination from insanitary objects to food: employees were observed handling trash, failing to wash or sanitize their hands and returning directly to product processing; employees carrying trays of crab cakes on their shoulders were seen to have their hair come into contact with product, and; an employee was observed drinking from a can of soda while manipulating crab cake product.
(b) Protection of food and food packaging materials from adulterants: raw, iced chicken was observed draining on the floor of the walk-in refrigerator unit; celery and parsley, used as ingredients in your crab cakes and lobster mash potatoes were observed stored directly on the floor in the same walk-in refrigerator unit, and; plastic wrap used to wrap trays of crab cakes was observed coming into direct contact with containers of window cleaner, bleach, and degreaser.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)) and the seafood HACCP regulation.
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 07054. If you have questions regarding any issues in this letter, please contact Mr. Manney at (973) 526-6008.
Douglas I. Ellsworth
New Jersey District