Inspections, Compliance, Enforcement, and Criminal Investigations

Flott S.P.A. 1/30/18



Black HHS-Blue FDA Logo



5001 Campus Drive
College Park, MD 20740 


JAN 30, 2018


Mr. Tommaso Tomasello, Chief Executive Officer
Flott S.P.A.
Via Olivuzza N. 5
Aspra, Palermo, 90010 Italy

Reference #542726

Dear Mr. Tomasello:

On October 23-24, 2017, a representative of the U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Flott S.P.A. located at Via Olivuzza N. 5, Aspra, Palermo, Italy. The inspection revealed serious violations of the seafood HACCP regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA's issuance of an FDA-483, lnspectional Observations, listing the deviations found at your firm. We acknowledge receipt of your responses sent on November 14, 2017, December 4, 2017, and January 9, 2018. However, our evaluation of the documentation revealed that these responses were not adequate, as further explained in this letter.

In accordance with 21 CFR 123, failure of a seafood facility to operate in accordance with the requirements of 21CFR123, renders the canned tuna 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 canned tuna product is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at

Your significant deviations are as follows:

1.    You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR Part 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels". However, your firm's revised HACCP plan entitled, "Tuna in Olive Oil - Tuna in Natural Water" does not list the critical control points of thawing and unrefrigerated processing [i.e., cutting, hand filling, capping, and staging prior to sterilization (i.e ., until the product achieves an internal temperature sufficient to destroy the vegetative cells of the microorganisms of concern)] for controlling the food safety hazard of scombrotoxin (histamine) formation, specifically:

a.  With reargd to thawing, although your firm explained to our investigator that you (b)(4) your firm does not include this as a critical control point in your HACCP plan to ensure that all lots of frozen fish are thawed under conditions that control scombrotoxin (histamine) formation. Once included as a critical control point, FDA recommends you implement procedures to ensure the tuna products are continuously held at or below 40°F (4.4°C) during the entire thawing process.

b.  With regard to processing, our investigator observed that your firm performs (b)(4) processing steps under unrefrigerated conditions which cumulatively may lead to scombrotoxin (histamine) formation as a result of time and temperature abuse. FDA recommends that your firm include a critical control point cumulatively combining all processing steps; or critical control points for each individual processing step in your HACCP plan. Once included as one or multiple critical control points, FDA recommends implementing procedures to ensure:

o The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 12 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C); OR
o The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 24 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C).

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, including your revised HACCP plan and five (5) consecutive days of completed monitoring records (i.e ., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. Responding in English will help to assist us in our review of your documentation.

If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your canned tuna products under section 801(a) of the Act (21 U.S.C. 381(a)) including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation (21 CFR 123) is Import Alert 16-120, Detention without Physical Examination of Fish and Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP. This alert can be found on FDA's web site at:

This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the Seafood HACCP regulations (21 CFR 123), and the current Good Manufacturing Practices regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re -inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.

Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, Office of Compliance, Division of Enforcement, Food Assessment and Adulteration Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Rosemary Sexton via email at Please reference case#542726 on any submissions and within the subject line of any emails to us.

William A. Correll, Jr.
Office of Compliance
Center for Food Safety
    and Applied Nutrition 

Page Last Updated: 10/03/2018
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