Inspections, Compliance, Enforcement, and Criminal Investigations
Marpesca Miami Corporation 14-Apr-05
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
April 14, 2005
Mr. Dario M . Picans
Marpesca Miami Corporation
7875 NW. 12th Street, Ste. 101
Miami, FL 33126-1815
Dear Mr. Picans:
On February 2-3, 2005, the Food and Drug Administration conducted an inspection of your facility located at the above address. The inspection was conducted to determine your firm's compliance with FDA's seafood processing regulations (21 CFR 123).
During our inspection, the FDA investigator observed deviations from the seafood HACCP regulations . The FDA Investigator also provided your employee, Juan C. Picans, with a copy of the form FDA 483 (copy enclosed), which presents her 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, our firm did not perform an affirmative step for mahi-mahi manufactured by [redacted] in Panama. This same deviation was previously pointed out to you in our letter dated November 15, 2003 (enclosed).
Additionally, the HACCP plans from your foreign processor [redacted] have not been signed and dated on an annual basis, and a written guarantee has not been provided.
The above identified deviations are not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to ensure that all seafood products imported, processed and distributed by your firm are in compliance with the Act and all requirements of the federal 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 detain your imported seafood products without examination. Under such conditions, FDA will not issue any Certificates for Export or European Union Health Certificates for any of the affected fish and fishery products processed at your facility.
Please notify this office in writing within 15 working days from your receipt of this letter of the specific steps you have taken to correct these violations, including an explanation of each step taken to prevent their reoccurrence. Your response should include copies of any available documentation demonstrating that corrections have been made. If corrections cannot be completed within 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: Virginia L. Meeks, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32571. If you have questions regarding any issue in this letter, please contact Ms. Meeks at (407) 475-4731. We look forward to working with you to achieve a successful HACCP program.
Emma K . Singleton
Director, Florida District