Inspections, Compliance, Enforcement, and Criminal Investigations
Goya Foods of Florida 21-Oct-03
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
Return Receipt Requested
October 21, 2003
Robert I. Unanue, President
Goya Foods of Florida
P.O. Box 226110
Miami, Florida 33122
Dear Mr. Unanue:
On August 28-29, 2003, 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 HACCP Regulations (21 CFR Part 123).
During our inspection, the FDA investigator observed shortcomings in your import verification procedures that, upon our preliminary review, appear to be 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 his evaluation of your firm's performance regarding various aspects of the HACCP requirements. The observations of concern to us are 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 regulations to comply with 21 CFR 123.12(a)(2)(ii). However, your firm performed an affirmative step of maintaining on file a copy in English of the foreign processor's HACCP plan for Bonita in olive oil manufactured by [redacted] that was not adequate. The HACCP plan from [redacted] for Scombrotoxin forming fish does not list the critical limit of internal temperature of the fish at the receiving critical control point, and does not list the monitoring frequency of the number of fish to be tested in every incoming lot for histamine analysis. [21 CFR 123.6(c)(3) and (4) ]
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 performed an affirmative step of maintaining on file a copy in English of the foreign processor's HACCP plan for Bonito (solid pack) in olive oil manufactured by [redacted] by that was not adequate. The HACCP plan from [redacted] for Bonito (solid pack) in olive oil does not list the critical limit at the receiving critical control point of sensory examination of a representative number of fish, lists an inadequate temperature of 45°F for incoming fish, and does not list the monitoring frequency of the number of fish to be tested for histamine analysis in every incoming lot. [21 CFR 123.6(c)(3) and (4)
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 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 respond in writing within fifteen (15) working days of your receipt of this letter. Your response should outline the specific steps you have taken to correct these violations. Your response should include copies of any available documentation demonstrating that the corrections have been made. If the corrections cannot be completed with 15 working days, state the reasons for the delay and the timeframes within which you will correct any remaining deviations.
Please send your reply 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 any issue in this letter, please contact Ms. Englund at (407) 475-4741.
Florida District Office