Caseificio Sociale Manciano 7/5/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
VIA EXPRESS DELIVERY
Mr. Carlo Santarelli, President
Caseificio Sociale Manciano
Localita Piano di Cirignano
58014 Manciano (GR), Italy
Reference No.: 314819
Dear Mr. Santarelli:
The U.S. Food and Drug Administration (FDA) inspected your cheese processing facility, Caseificio Sociale Manciano, located at Localita Piano di Cirignano, 58014 Manciano, Italy on February 16-17, 2012. During that inspection, we found that your firm had serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Parts 110). This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviations found at your firm. Based on our review, your Pecorino Toscano D.O.P., Pecorino Viminato and Crotonese, Bianchetta Truffle Cheese, and Pecorino Nocino with Walnuts cheeses are 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 they have 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. In addition, we have reviewed your labels and found that your products are misbranded within the meaning of Section 403(h)(3) of the Act, 21 U.S.C. § 343(h)(3). 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 sent via email on March 9, 2012 and find that the response is inadequate to alleviate our concerns with your firm’s pasteurizers. Your firm’s significant deviations are as follows:
• Failure to design equipment to preclude the adulteration of food as required by 21 CFR 110.40(a). Specifically, the flow diversion valves (FDVs) on your (b)(4) are located after the regeneration and cooling sections, which can cause contamination of milk in the post-heating regeneration section, the cooling section, and associated piping with under-pasteurized milk in the event of a flow divert situation. FDA recommends relocating the FDVs to a point at the end of the holding tubes and before the pasteurized side of the regenerator.
In your response letter dated March 9, 2012, you state that if the temperature recording device located at the end of the hold tube and linked to the FDVs, measures the temperature as (b)(4) the flow divert valve would activate, and the milk would not be sent to processing and that staff would stop pasteurization and continue pasteurization with the other pasteurizer. This proposed correction, which does not include the relocation of the FDVs, does not address the concern that under-pasteurized milk may contaminate the post-heating regeneration section, the cooling section, and associated piping of your pasteurizers. At the conclusion of the inspection you indicated that in the event of a flow divert situation, the pasteurizer would be cleaned-in-place (CIP) prior to continuing to use the equipment to pasteurize milk. FDA finds that your proposed actions mitigate the concern for contamination in the short term, but do not adequately address the lack of adequate equipment design. If you have data to show that you have verified that your system, as currently designed, is appropriate to minimize the potential for contamination and growth of pathogenic microorganisms from under-pasteurized milk, please submit the data as part of your response to this letter.
• Your Pecorino Toscano D.O.P., Pecorino Viminato and Crotonese, Bianchetta Truffle Cheese, and Pecorino Nocino with Walnuts cheeses are misbranded within the meaning of Section 403(h) of the Act, 21 U.S.C. § 343(h), in that their ingredients purport to be pasteurized sheep’s or cow’s milk, but you do not pasteurize the milk used to manufacture these cheeses to the specified time and temperature parameters identified in 21 CFR 1240.61, nor have you submitted notification to FDA, including effectiveness data, that demonstrates that your current process or treatment meets the four requirements set forth in Section 403(h)(3)(B)(i) of the Act.
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. 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