Inspections, Compliance, Enforcement, and Criminal Investigations
Apollo Export Warehouse, Inc. 25-May-05
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
May 25, 2005
Rafael A. Ordonez, President
Apollo Export Warehouse, Inc.
1775 NW 70th Avenue
Miami, Florida 33126-1341
Dear Mr. Ordonez:
On February 22 and 23, 2005, the Food and Drug Administration (FDA) 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 by your firm from the special requirements for imported products (21 CFR 123.12). You can find the seafood HACCP regulations and the Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 301, through links in FDA's homepage at http://www.fda.gov.
The observations of concern to us are as follows:
1.You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm does not have product specifications for frozen smoked Salmon and frozen whole Salmon imported from Norway.
2.You must 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 perform an affirmative step for frozen smoked Salmon manufactured by [redacted] and frozen whole Salmon manufactured by [redacted].
These same deviations, involving a different forelgn processor, were previously brought to your attention during our inspection in October 2003.
The above identified deviations are not intended to be an all inclusive list of the 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 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, the FDA may detain your imported seafood products without examination. Under such conditions, the 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 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 recurrence. 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 your 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: Diane J. Englund, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions regarding the implementation of the seafood HACCP regulations or for answers and/or directions toward guidance and sources of training in achieving compliance, you may contact Ms. Englund at (407) 475-4741.
We look forward to working with you to achieve a successful HACCP plan.
Director, Florida District