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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Seafarers Inc. 24-May-05

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



HAND DELIVERED

WARNING LETTER
FLA-05-32

May 24, 2005

Guillermo A . Rosell, President
Seafarers Inc.
5900 NW 97th Avenue, Suite No. 18
Miami, Florida 33178

Dear Mr. Rosell:

On February 9, 2005, the Food and Drug Administration (FDA) conducted an inspection of your seafood importing facility located at 5900 NW 97th Avenue, Bay #18, Miami, Florida 33178. 'The inspection was conducted to determine your firm's compliance with FDA's seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123).

During our inspection, we observed a serious deviation from the principle of HACCP and the significant requirements of the program. Our investigators provided you with the Inspectional Observations (form FDA 483), which presents their evaluation of your firm's performance regarding various aspects of the HACCP requirements. The observation of concern to us is as follows:

1. You must implement an affirmative step which ensures 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, no affirmative step was performed for fresh tuna imported from [redacted]. This observation is similar to an observation from our March 12-18, 2002 inspection of your facility, where we noted that there were no records available to indicate that fresh tuna that you received from another foreign processor had been processed under conditions that comply with the seafood HACCP regulations.

We acknowledge receipt of your written response dated March 2, 2005 and accompanying documentation. However, we find your response fails to provide proper corrective action in that the [redacted] HACCP plan provided lists inadequate critical limits and monitoring procedures at "Receiving" or a primary processor of fresh histamine forming fish. The HACCP plan also fails to include a storage critical control point as designated in the primary processor's hazard analysis.

We also note that your written verification procedures list multiple affirmative steps that your firm may choose to implement. These steps include maintaining the HACCP plan and written guarantee of the foreign "supplier." However, an appropriate affirmative step requires maintaining the HACCP plan, in English, and a written guarantee from the foreign processor, in order to comply with 21 CFR 123.12 (a)(2)(ii)(D). We suggest that you revise your written procedures.

The above identified deviation is not intended to be an all inclusive list of deficiencies at your facility . It is your responsibility to ensure that all seafood products processed and distributed by your firm are in compliance with the Act and applicable regulations. You should take prompt measures to correct these deviations. Failure to promptly correct the deviations noted may result in regulatory action without further notice. Such action includes seizure and/or injunction. In addition, FDA may take steps to refuse your imported seafood products, including placing them on detention without physical examination, until the violation is corrected. Under such conditions, FDA will not issue any Certificates to Foreign Governments for any of the affected fish and fishery products processed at your facility.

Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct these violations, including an explanation of each step take to prevent their reoccurrence. Your response should include copies of any available documentation demonstrating that corrections have been made. If corrections cannot be completed with 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.

Your reply relating to these concerns should be directed 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 the implementation of the HACCP Regulations, please contact Ms . Shambaugh at (407) 475-4730 for answers and/or direction towards guidance and sources of training in achieving compliance.

We look forward to working with you to achieve a successful HACCP program.

Sincerely,
/s/
Emma R. Singleton
Director, Florida District