Inspections, Compliance, Enforcement, and Criminal Investigations
Lumax Handling Corporation 16-May-06
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
May 16, 2006
Juan X. Perrone, President
Lumax Handling Corporation
2000 N.W. 95th Ave.
Doral, FL 33172
Dear Mr. Perrone:
We inspected your seafood processing facility, located at 2000 N.W. 95th Ave., Doral, Florida, on March 2nd & 3rd, 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(a)(4). Accordingly, your canned crabmeat and fresh mahi 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 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 pasteurized canned crabmeat to control the hazards of pathogen growth and Clostridium Botulinum toxin formation.
2. Since you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for histamine forming fish at the receiving and storage critical control points to control Histamine and Scombrotoxin formation are not appropriate in that, your corrective plan does not include the discontinuation of supplier or carrier until evidence is obtained that transportation practices have changed; And, the corrective action plan at the storage critical control point does not include making repairs or adjustments to malfunctioning cooler or moving product to reduce time/temperature exposure.
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 following:
condition and cleanliness of food contact surfaces
prevention of cross-contamination from insanitary objects
protection of food packaging material
food contact surfaces from adulteration and exclusion of pests
with sufficient frequency to ensure control as evidenced by chlorine sanitizer with a concentration of 10ppm, the tip of the water hose use to clean and sanitize food contact surfaces was in direct contact with the floor, lack of paper towels, soap and hot water in the hand sink, accumulation of stagnant water on the floor and ice chute curtains covered with mold.
4. You must implement an affirmative step which ensure that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for fresh whole mahi imported from [redacted]
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: Jimmy Walthall, Director of Compliance, 555 Winderley Place Ste 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Mr. Walthall at (407) 475-4734.
Emma R. Singleton
Director, Florida District