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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ally K. Enterprise Corporation 16-Oct-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


555 Winderley Pl., Ste. 200
Maitland, Fl 32751




October 16, 2007

Mr. Gildardo Augusto Lema
Ally K. Enterprise Corporation
2050 NW 70th Street
Miami, Florida 33122

Dear Mr. Lema:

We inspected your seafood processing facility, located at the above address on July 18-20, 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 (C.F.R.), Part 123 (21 C.F.R. 123). In accordance with 21 C.F.R. § 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 refrigerated canned pasteurized crabmeat, vacuum-packaged fin-fish products (i.e. mahi-mahi), and scombroid-forming species 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:

• You must conduct a hazard analysis for each kind of fish or, fishery product you process to determine whether there are food safety hazards that are reasonably likely to occur, and to identify the preventive measures that you can apply to control those hazards, to comply with 21 C.F.R. § 123.6(a). You also must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 C.F.R. § 123.6(b).
However, your firm does not have a HACCP plan for:

o Refrigerated canned pasteurized crabmeat to, control the food safety hazard of Clostridium botulinum toxin formation.

o Refrigerated vacuum-packaged fin fish products, i.e. mahi-mahi, to control the food safety hazard of Clostridium botulinum toxin formation.

• You must have and implement a HACCP plan that lists the "critical control points" as defined at 21 C.F.R. § 123.3(b) for each identified food safety hazard, and provide for a record keeping system that documents and monitors the critical control points, to comply with 21 CFR 123.6(c)(7). However, your firm did not record monitoring observations and follow the monitoring procedures at the receiving and storage critical control points to control histamine/scombrotoxin formation listed in your HACCP plan for histamine producing fish.

In addition, your HACCP plan under monitoring "A" for the, critical control point of storage states that you will monitor the cooler temperature "[redacted]." The FDA does not consider intermittent temperature checks during storage periods to be an adequate method of assuring that histamine producing fish is held at safe temperatures throughout storage. If your products are not stored with ice or cooling media, FDA would expect some method of continuous temperature monitoring such as a time/temperature data logger, recorder thermometer or a high temperature alarm with 24 hour monitoring. This monitoring frequency would be continuous by the instrument itself with a visual check of the instrument at least once per day.

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 day, 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: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions regarding any issue in this letter, please contact Mr. Schroeder at (407) 475-4763.



Emma R. Singleton
Director, Florida District