| Public Health Service Food and Drug Administration |
Florida District |
Department of Health and Human ServicesCERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-11-41
September 6, 2011
Mr. Lexis Varona
President
24/7 Seafood Distributor Corp.
Lexis M. Varona, President
265 West 27th Street
Hialeah, FL 33010
Dear Mr. Varona:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at the above referenced address on May 23, 2011. 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), and the Current Good Manufacturing Practice (CGMP) regulation for food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 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, the raw, fresh, refrigerated scombroid fish processed by your firm, which include sushi grade tuna (intended to be consumed raw) and whole, filleted, and/or loined tuna, escolar, and wahoo (intended to be cooked prior to consumption), 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 and food regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links on FDA's home page at www.fda.gov.
Your significant regulatory deviations were as follows:
1. You must have a HACCP plan that, at a minimum, lists the 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’s HACCP plan for “Fresh, Whole Filleted or Loined Tuna[…] Escolar and Wahoo,” does not list the food safety hazard(s) of pathogenic bacteria growth.
During the inspection, you informed our Investigator that the raw, fresh, refrigerated, scombroid fish products processed by your firm included sushi grade tuna for sushi markets. However, your firm’s HACCP plan for “Fresh, Whole Filleted or Loined Tuna[…] Escolar and Wahoo,” which states that the products are intended to be “Cooked before Consumption,” does not address the significant hazard of pathogenic bacteria growth due to time and temperature abuse—a process-related hazard for ready-to-eat (RTE) foods such as sushi grade tuna—at the receiving and product storage CCPs.
2. You must implement the recordkeeping system that you listed in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the receiving and product storage CCPs to control the significant hazard of histamine formation as listed in your HACCP plan for “Fresh, Whole Filleted or Loined Tuna […] Escolar and Wahoo.” For example, your purchasing records indicated that you received at least four (4) shipments of raw, fresh, refrigerated, headed and gutted tuna on April 14, 19, and 21, 2011, and May 18, 2011. However, as of the time of the current inspection, your “Product Receiving Records” had not been completed since February 5, 2011, and your “Cooler Temperature/Presence of Ice Surrounding Product” records had not been completed since March 4, 2011.
3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plans for “Fresh, Whole Filleted or Loined Tuna […] Escolar and Wahoo” at the receiving and product storage CCPs are not appropriate for the following reasons:
A. Your corrective action plan for critical limit deviations at the receiving CCP (“Reject lot”) does not address what steps you would take to prevent the same or similar deviations to your critical limits (“There should be adequate Ice or Coolant at the time of delivery… Internal Temperature 40°F or below”) from recurring in the future.
B. Your corrective action plan for critical limit deviations at the product storage CCP (“Move Product from Malfunctioning Cooler to another Cooler… Add ice”) fails to address how you will ensure the safety of the affected product following deviations to your critical limits (“Product Storage at 40°F or below… Or/and… Product held under Ice”) and how you will prevent the same or similar deviations to your critical limits from recurring in the future.
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110 to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces and the maintenance of hand washing, hand sanitizing, and toilet facilities with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR part 110 as evidenced by the following:
A. On May 23, 2011, at least one (1) of your employees was observed washing a cutting board used in your firm’s fish cutting operations with anti-bacterial hand soap. Hand soap is not appropriate for use in cleaning processing equipment in seafood manufacturing operations. The same employee was then observed spraying the cutting board with a spray bottle which the employee identified as containing a chlorine-based sanitizing solution. However, when we tested the sanitizing solution, we found no detectable levels of available chlorine (i.e., 0 ppm Cl2) in the solution.
B. On May 23, 2011, there was no hand-washing sink in the employees’ restroom. In addition, there were no hand drying devices or paper towels available at the two (2) hand-washing sinks in your firm’s processing and warehouse areas.
5. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b) to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for safety of water that comes in contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, required for the processing of “Fresh, Whole Filleted or Loined Tuna […] Escolar and Wahoo,” since the previous inspection of your firm on April 15 and 17, 2009.
At the conclusion of the inspection on May 23, 2011, you verbally promised our Investigator that you would immediately begin correcting the referenced deviations and submit a written response to FDA within fifteen (15) days. However, as of the date of this letter, we have not received a written response from you.
FDA 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.
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 revised and/or new HACCP plan(s), monitoring, and verification records; sanitation control records; facility and equipment maintenance service invoices and/or photographs of facility and equipment repairs; 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 seafood processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for food (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 attention of Matthew B. Thomaston, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, you may contact Mr. Thomaston via email at Matthew.Thomaston@FDA.HHS.GOV or via telephone at (407) 475-4728.
Sincerely,
/s/
Elizabeth W. Ormond
Acting Director, Florida District
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