Inspections, Compliance, Enforcement, and Criminal Investigations
Ocho Rios Miami Inc. 08-May-07
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
May 8, 2007
Aston Lue, President
Ocho Rios Miami Inc.
2051 NW 15th Avenue
Miami, Florida 33142
Dear Mr. Lue:
We inspected your seafood processing facility, located at 2051 NW 15th Avenue, Miami, Florida 33142 on April 2-3, 2007. 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 vacuum packaged pickled split mackerel and salted mackerel in brine 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 or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement 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 our inspection found your firm again failed to conduct a hazard analysis for any of the seafood products distributed by your firm and your firm does not have HACCP plan(s) to control the food safety hazards in refrigerated seafood products such as vacuum packed pickled split mackerel and salted mackerel fillets in brine.
2. 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 any sanitation monitoring records.
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.
In addition, we remind you that 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, our inspection found that your firm did not monitor the eight areas of sanitation to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by the CGMP deficiencies observed during our inspection including the observation of a dead rodent, rodent excreta pellets, and possible haborage areas for pests. We also remind you that your firm should use insecticides as permitted only under appropriate precautions to protect against contamination of the food, food contact surfaces, and food packaging materials to comply with 21 CFR 110.35(c).
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: Shari H. Shambaugh, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Shambaugh at 407-475-4730.
Emma R. Singleton
Director, Florida District