Inspections, Compliance, Enforcement, and Criminal Investigations
Ciresa Formaggi Snc 7/9/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
July 9, 2012
VIA EXPRESS DELIVERY
Mr. Alberto Ciresa
General Manager and Part Owner
Ciresa Formaggi, Snc.
Via Vittorio Emanuel 62
23815 Introbio (LC), Italy
Reference No.: 322658
Dear Mr. Ciresa:
The U.S. Food and Drug Administration (FDA) inspected your cheese processing facility, Ciresa Formaggi, Snc., located at Via Vittorio Emanuel 62, Introbio, Italy on January 30-31, 2012. During that inspection, we found that your firm had serious deviations from the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). At the conclusion of the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, that listed the deviations found at your firm. Based on the inspection findings, your Taleggio D.O.P. cheese is 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) in that it has been prepared, packed, or held under insanitary conditions whereby the cheese may have become contaminated with filth or may have been rendered injurious to health. You may find the Act and FDA’s regulations through links in FDA's home page at www.fda.gov.
We have evaluated your response to the FDA-483 sent via email on February 21, 2012 and find that the response is inadequate with regard to your firm’s use of (b)(4). Your firm’s significant deviation continues to be as follows:
Your firm does not use plant equipment materials, namely the (b)(4), that allow for adequate cleaning and sanitizing to comply with 21 CFR Part 110.40(a). Specifically, the (b)(4) that are used to store cheese during the aging step, including Taleggio DOP, are not composed of a smooth, cleanable surface and were observed to contain rough areas and splintered (b)(4). Food contact surfaces must be designed to withstand the environment of their intended use and cleaning compounds and sanitizing agents. Cheese is placed on cotton cloths inside these (b)(4); however, our investigator observed the sides of cheese in direct contact with the (b)(4) surface. We acknowledge that you conduct periodic testing of Listeria spp. on your cheese products; however, that does not replace the requirement under the CGMP regulations to use materials that can be adequately and suitably cleaned.
In your response to the FDA-483, your firm informed us that you have placed larger cloths in between the (b)(4); however, we do not consider this an adequate corrective action. This change still does not enable adequate cleaning and sanitizing of the (b)(4) used for aging. Further, the cloths are porous and absorbable and thus capable of allowing organic matter, including bacteria, to penetrate through the cloths from (b)(4).
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 this violation. Your response should include documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen 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 action to refuse admission of your imported cheese 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 which 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 firm operates in compliance with all applicable parts of the Act and regulations, including the current Good Manufacturing Practices regulation for foods (21 CFR Parts 110).
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 send your reply to the U. S. Food and Drug Administration, Attention: Doriliz De Leon, Office of Compliance, Division of Enforcement, Food Adulteration Assessment 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 Ms. De Leon at (240) 402-2772 or via email at Doriliz.DeLeon@fda.hhs.gov.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition