Inspections, Compliance, Enforcement, and Criminal Investigations
Vistar Corporation 12/22/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
December 22, 2010
Mr. Wayne L. Entsminger
3595 Nw 125th St,
Miami, FI 33167-2413
Dear Mr. Entsminger:
We inspected your seafood processing facility, located at 3595 Nw 125th St. Miami, FL from October 18, 2010 to October 21,2010. 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 frozen cooked ready to eat Snow Crab, your canned pasteurized crabmeat and your frozen cooked lobster 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:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as the "maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard". However,
• Your firm's HACCP plan for frozen cooked lobster lists a critical limit that does not ensure control over one or more hazards. The HACCP plan does not include the length of the cook cycle, the temperature of the steam, and the minimum or maximum size of the lobster. FDA recommends that you establish these parameters through scientific studies.
• Your firm's HACCP plan for "Crab Product" lists a critical limit of, "Product NTE 40°F at time of receipt" which is not adequate to control for the hazard of pathogen growth during transit. FDA recommends continuous monitoring of product or ambient temperature during transit.
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 HACCP plan for cooked lobster entitled "Frozen or Fresh Spiny Lobster" does not include the monitoring procedure for the length of the cooling cycle, the type of thermometer used to monitor the internal temperature of the product, the method used to monitor the length of the cooling cycle, and the frequency for monitoring the critical factors in the cooling cycle.
• Your firm's HACCP plan for frozen cooked lobster entitled "Frozen or Fresh Spiny Lobster" does not include monitoring for the declaration of presence of sulfiting agents on cartons and labeling, the method and the frequency of monitoring at the "Addition/Labeling of Sulfites CP.
3. You must adequately monitor sanitation conditions and practices during processing to comply with 21 CFR 123.11 (b). However, your firm did not monitor the cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, and maintenance of hand washing, hand sanitizing, and toilet facilities with sufficient frequency to ensure control as evidenced by:
•The employee that received the cooked ready to eat stone crab claws on 10/19/2010 did not wash/sanitize his hands. Our investigator observed the employee handling shipping cartons and mesh bags with exposed stone crab claws while checking the temperature of the product.
•Your firm was splitting frozen, cooked snow crabs and packaging the product into cartons that had liners that were in direct contact with old chemical containers that were not properly cleaned and sanitized. At the end of the packaging process, the plastic liners were folded inside the carton and came into direct contact with the ready to eat frozen stone crabs.
•On 10/19/2010 our investigator observed that two employees conducting the cleaning operation of the electric band saws in processing room (b)(4) did not use any sanitizing solution.
•There was no hot water available at the hand wash station outside of the processing rooms (b)(4) and (b)(4)
•There was no hand soap available at the hand wash station in the ladies' restroom.
•On 10/19/2010 our investigator observed during the cleaning operation of the processing rooms (b)(4) and (b)(4) three hoses ends in direct contact with the floor of the processing rooms.
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 receipts of this letter. Your response should outline the specific things you are doing to correct these violation. 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.
We acknowledge your response to the FDA 483 received on December 7,2010. We will review that submission together with your response to this letter once we have received it. Because your response to the FDA 483 was not received within 15 working days of the end of the inspection we were not able to respond to your submission in this letter.
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: Emma Singleton, District Director, 555 Winderley Place, Suite 200, Maitland Florida 32751. If you have questions regarding any issues in this letter, please contact Carla Norris at 407-475-4730.
Emma R. Singleton
Director, Florida District