Inspections, Compliance, Enforcement, and Criminal Investigations
Netuno USA, Inc. 17-May-05
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
May 17, 2005
Luciano R. Bonaido,
President, Netuno USA, Inc.
10305 NW 41st Street
Miami, Florida 33178-2976
Dear Mr. Bonaldo:
On March 29 & 30, 2005, the United States 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 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 you with a copy of a list of Inspectional Observations (FDA 483), a copy of which is enclosed, 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 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). Your firm, however, does not have product specifications for all seafood products imported into this country. For example, your firm could not provide documentation for product specifications for imported high-risk foods including fresh mahi-mahi and fresh mackerel. This same deviation was pointed out to you in our letter dated May 31, 2001.
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 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.
We acknowledge receipt of your firm's written response received in our, office on May 10, 2005, in reply to the current inspection concluded on March 30, 2005. The response has 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 response is only partially adequate, because it does not alleviate our concern in that it fails to address written product specifications.
We noted 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 that the imported fish or fishery product was processed in accordance with the seafood HACCP regulations. However, review of the foreign processor's HACCP plan for fresh fish (mahi-mahi) revealed the HACCP plan does not list the food safety hazard of histamines. We recognize in your response that your firm has contacted your foreign supplier and discussed the issues that were noted during our March 2005 inspection. We encourage you to continue communications with your foreign supplier and persuade them to make the appropriate correction.
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.
s R. Singleton
Director, Florida District