Inspections, Compliance, Enforcement, and Criminal Investigations

Cermaq Chile S.A. No. 10195 8/25/17

 

  

Black HHS-Blue FDA Logo5001 Campus Drive
College Park, MD 207 40

 

5001 Campus Drive
College Park, MD 20740
 

 
 

WARNING LETTER

AUG 25, 2017

VIA EXPRESS DELIVERY

Mr. Adolfo Mohr Buhler
Plant Manager
Cermaq Chile S.A. No. 10195
Ruta 5 Sur Kilometro 1105
Ancud, Chiloe, Chile

Reference# 534324

Dear Mr. Mohr Buhler:

On June 5 & 6, 2017, a representative of the U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Cermaq Chile S.A. No. 10195, located at Ruta 5 Sur Kilometro 1105 Ancud, Chiloe, Chile. That inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), referred to as seafood HAACP regulation. That inspection resulted in FDA's issuance of an FDA-483, lnspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. FDA did not receive a response from your firm regarding the form FDA-483 to this date.

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery 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 frozen vacuum-packaged aquacultured salmon are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and FDA's 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.

We note the following significant observation:

You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(l). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for frozen vacuum-packaged aquacultured salmon does not list the food safety hazard of Clostridium botulinum toxin formation. In addition to ensuring each vacuum-package is labeled with the statement "Keep Frozen, Thaw under Refrigeration immediately before use," FDA recommends implementing controls for Clostridium botulinum toxin formation during the refrigerated storage of in-process vacuum-packaged salmon. During the inspection, our investigator was informed that your vacuum-packaged salmon can remain in the refrigerator for up to 48 hours.

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, such as a revised HACCP plan and 5 days of monitoring records. 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.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported sea cucumber 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 regulations is Import Alert #16-120. This alert can be found on FDA's web site at www.accessdata.fda.gov/cms_ia/ialist.html.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation and the Good Manufacturing Practice 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, includ ing 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: Philip Bermel, Compliance Officer, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Philip Bermel via email at Philip.Bermel@fda.hhs.gov. Please reference CMS# 534324 on any submissions and within the subject line of any emails to us.

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

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