Inspections, Compliance, Enforcement, and Criminal Investigations
Vince & Sons Pasta Company 3/30/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
March 30, 2012
RETURN RECEIPT REQUESTED
Mr. Claudio Lauciello
Vince & Sons Pasta Company
7825 West 87th Place
Bridgeview, Illinois 60455-1864
Dear Mr. Lauciello:
We inspected your processing facility, located at 7835 West 87th Place in Bridgeview, Illinois on February 14 and March 06, 2012. 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 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor offish 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 vacuum packaged lobster product is adulterated, in that it has been prepared, packed, or held under unsanitary 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:
• You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur to comply with 21 CFR 123.6(b). Your firm does not have a HACCP plan for vacuum packaged lobster to control the hazard of C. botulinum growth.
• No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience to comply with 21 CFR 123.10. Your firm management has not taken a seafood HACCP course and is unfamiliar with seafood associated hazards.
We make 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 actions you are taking 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 violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations (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: Rosemary Sexton, Compliance Officer, 550 West Jackson Boulevard, Chicago Illinois 60661. If you have questions regarding any issues in this letter, please contact Ms. Sexton at (312) 596-4225.
Scott J. Maclntire