Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
May 3, 2005
Domingo A. Moreira
President, Ladex, LCC
7231 SW 63rd Avenue
Miami, Florida 33143
Dear Mr. Moreira:
On March 1 & 2, 2005, the United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 7231 SW 63rd Avenue, Miami, Florida 33143. The inspection was conducted to determine your firm's compliance with FDA's seafood Hazard Analysis Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123).
During our inspection, the FDA investigators observed deviations from the seafood HACCP regulations. The FDA Investigators provided Mercedes Iglesias, Sales Logistics, with a copy of the form FDA 483, a copy of which is enclosed with this letter, 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:
You must have written product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health or have not been processed under insanitary conditions, to comply with 21 CFR 123.12 (a)(2)(i). However, your firm does not have product specifications for.any seafood products imported into this country. For example, your firm could not provide documentation for product specifications for imported high-risk foods including mahi-mahi.
We acknowledge receipt of your firm's written responses, dated March 8, 2005, in reply to the current inspection concluded on March 2, 2005. The responses have been reviewed and will be made part of the official file. It appears that you are taking steps to bring your firm into compliance with the seafood HACCP regulations. However, your responses are only partially adequate, because they do not alleviate all of our concerns.
In your response you provided a copy of your foreign processor's "Frozen shrimp" HACCP plan from [redacted]. It appears that your firm has selected the affirmative step of maintaining on file a copy, in English, of the foreign processor's HACCP plan. and a written guarantee from the foreign processor to comply with CFR 123.12 (a)(2)(ii). The copy of the HACCP plan you provided was not signed or dated as required by the HACCP regulations. In your response there is no documentation that a written guarantee was provided from your foreign processor. The product safety specifications provided for shrimp appear adequate; however, no other product specifications, e.g. mahi-mahi, were provided.
The above-listed 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 may include 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 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 or the delay and the time frame within which the corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding any issue in this letter, please contact Mr. Schroeder at (407) 475-4763. We look forward to working with you to achieve a successful HACCP program.
Director, Florida District