Inspections, Compliance, Enforcement, and Criminal Investigations
Angelines's Seafood Inc 15-Oct-03
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
October 15, 2003
Jorge A. Ramos, President
Angelines's Seafood, Inc.
7850 SW 24th Street
Miami, FL 33155
Dear Mr. Ramos:
On July 1, 2003, the Food and Drug Administration, (FDA) conducted an inspection of your seafood import operation located at the above address in Miami, Florida. The inspection was
conducted to determine your firm's compliance with FDA's seafood HACCP regulations [21 CFR 123].
During this inspection, the FDA investigator observed short comings in your import
verification procedures that are deviations from the requirements of the seafood. HACCP
regulations. The investigator also provided you with a list of Inspectional Observations (Form FDA
483), which presents her evaluation of your firm's performance regarding various aspects of the
HACCP requirements. In accordance with 21 CFR 123.6(g), failure of a processor to have and
implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 123, renders the fish and 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 imported snapper and grouper from [redacted] are adulterated in that
these products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act, and seafood HACCP regulations through links in FDA's homepage at http://www.fda.gov.
Specifically, we observed the following deviation:
You are required to implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulations, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not implement an affirmative step for the snapper and grouper that you import from [redacted]. Your written verification procedures state that you will obtain and maintain on file a copy of the foreign processes HACCP plan and a written guarantee stating that the imported fish is processed in accordance with the requirements of 21 CFR 123.12. Given that you have chosen to implement this affirmative step, you were then required under 21 CFR l23.12(a)(2)(ii)(D) to maintain English copies of these documents,and to maintain on file a written guarantee from the foreign processor, [redacted] both of which you failed to do. A similar deviation was previously brought to your attention in our letter of December 19, 2002.
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 all requirements of the federal regulations.
You should take prompt measures to correct this deviation. Failure to promptly correct this deviation 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 fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct this deviation, including an explanation of each step taken to prevent its 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, please 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: Brant M: Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, you may contact Mr. Schroeder by telephone at (407)475-4763.
Emma R. Singleton
Director, Florida District