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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Boston Seafood Wholesale LLC 29-Sep-05

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

Public Health Service
Food and Drug Administration
  555 Winderley PI., Ste. 200
Maitland, FL 32751




September 29, 2005

Brian F. Carlos, Owner/President
Boston Seafood Wholesale LLC
6805 NW 18th Drive
Gainesville, FL 32653

Dear Mr. Carlos:

We inspected your seafood processing facility, located at 6805 NW 18th Drive Gainesville, Florida on June 7-9, 2005. 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 histamine forming fish 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 Part 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 "Histamine Producing Species-Fresh not Frozen" lists the critical limit of "Ice must be totally surrounding fish . . . If not, temp must be 40 degrees or less at portion of fish that is not in ice" at both the Receiving and the Storage critical control points that is not adequate to control the hazard of scombrotoxin formation.

(a) Receiving: FDA does not recommend reliance on measurement of internal fish temperatures at the time of receipt as an adequate control for scombrotoxin formation by a secondary processor. While your critical limit to ensure that fish are totally surrounded by ice at the time of receipt is an appropriate control approach, your inclusion of a default alternative in event that the fish arrive with inadequate ice coverage is 1) actually a condition that should be considered. a corrective action, and 2) does not provide adequate assurances that the fish were not exposed to time/temperature conditions conducive to scombrotoxin formation during the transit period or that the fish are safe. The internal temperature measurement does not represent an adequate critical limit or an adequate corrective action control approach. Consequently, it's inclusion as your critical limit renders your critical limit inadequate.

(b) Storage: FDA recommends either adequate coolant (such as ice) around the fish or maintaining constant temperatures at 40°F or below to control histamine formation in histamine-forming fish dining storage. Just as at receipt, your default alternative to adequate ice, "If not, temp must be 40 degrees or less at portion of fish that is not in ice is to measure the internal temperature" makes the "Storage" critical limit inadequate and is likewise not an adequate corrective action.

Further, we note that you check ice twice a day. While FDA's Fish & Fishery Products Hazards & Controls Guide, 3rd edition, recommends a monitoring procedure to control scombrotoxin formation during storage by checking for the adequacy of ice surrounding the fish "at least twice per day" if you determine that ice is depleted between observations, the monitoring frequency is inadequate.

2. 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 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 canned pasteurized crabmeat to control the food safety hazard of pathogen growth and toxin formation, including Clostridium botulinum.

3. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the "Storage" critical control point for product received June 3, 2005 to June 7, 2005 related to the adequacy of ice checks to control histamine formation as listed in your HACCP plan for histamine forming species.

In addition, the FDA has determined that your facility is subject to the registration requirement in 415 of the Act [21 U.S.C. 350d] and our implementing regulation at 21 CFR Part 1, Subpart H. During our inspection, you were advised of this requirement. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act [21 U.S.C. 331(dd)]. Our records indicate that, to date, your facility has not been registered with FDA. We request that you, as the owner and sole agent, register the facility with FDA within 15 working days of the date of this letter. Registration may be accomplished online at http://www.access.fda.gov.. We encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. Alternatively, you may contact the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156 to inquire about mail or fax registration and related forms.

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: Shari H. Shambaugh, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 33751. If you have questions regarding any issue in this letter, please contact Ms. Shambaugh at 407-475-4730.



Emma R. Singleton
Director, Florida District.