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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Inaudi Commerciale Srl 8/13/10

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD


 

August 13, 2010

WARNING LETTER

VIA OVERNIGHT MAIL

Mr. Clemente Inaudi
President/Co-Owner
Inaudi Commerciale Srl.
Corso Mazzini 148
Borgo San Dalmazzo,
Italy

Reference: Case # 120488

Dear Mr. Inaudi:

FDA inspected your facility located at Corso Mazzini 148, Borgo San Dalmazzo, Italy on April 26-28, 2010. We found that your firm had serious deviations from the low-acid canned food regulations (21 CFR Parts 108 and 113). Failure to comply with all of the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113 constitutes a basis for the immediate application of the emergency permit control provisions of section 404 of the Act; and, particularly, implementation of 21 CFR 108.35(k) for products offered for entry into the United States. In addition, such failure renders your low-acid canned food 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 truffles product is adulterated in that the product has been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. You can find the Act and the low-acid canned food regulations through links in FDA's home page at http://www.fda.gov.

Your significant violations were as follows:

• Your firm could not provide documentation supporting that the scheduled process for canned sliced truffles was established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers and having adequate facilities for making such determinations as required by 21 CFR 113.83.

• Your firm could not provide evidence in the form of heat distribution data that your retorts accomplish adequate venting of air in accordance with 21 CFR 113.40(a)(12)(iii).

• Your firm's Colussi retort did not have a mercury-in-glass thermometer installed in accordance with 21 CFR 113.40(a)(1), nor an equivalent.

• Your firm failed to record processing and production information at the time it was observed by the retort operator, including the actual processing times and thermometer readings, in accordance with 21 CFR 113.100(a)(1).

• Your firm failed to conduct and record results of routine can double seam teardown exams in accordance with 21 CFR 113.60(a)(1).

We acknowledge your firm's response dated May 1, 2010 to FDA in regard to the deviations identified during the inspection. Your response proposes corrections but does not provide any specific evidence of corrections now in place for the LACF deviations or how or when the corrective actions would be implemented. Therefore, your response does not adequately address all the significant deviations identified.

You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) 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 low-acid canned food 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 canned food regulations (21 CFR Part 108 and 113) is Import Alert #99-04. This alert can be found on FDA's web site at: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the low-acid canned food regulations (21 CFR Part 108 and 113), and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Please send your reply to the U. S. Food and Drug Administration, Attention: Donald W Greaves, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Mr. Greaves at (301) 436-2057 or via email at dgreaves@cfsan.fda.gov.

Sincerely,

/s/

 

Jennifer A. Thomas
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition