| Public Health Service Food and Drug Administration |
| Washington, DC |
Department of Health and Human ServicesJune 16, 2010
WARNING LETTER
VIA OVERNIGHT MAIL
Mr. Pablo Cruz Perez
President
Cruz Perez Hermanos S.A.
Calle Rosalla De Castro 4
Moana Pontevedra, Spain
36959
Reference No: 106727
Dear Mr. Cruz Perez:
FDA inspected your low-acid canned food facility located at Calle Rosalla De Castro 4, Apartado No.5, Moana Pontevedra, Spain, on February 15-19, 2010. During that inspection, 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 prima facie 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 product, Octopus in Oil, 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.
This inspection resulted in FDA's issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. Your firm provided a response in Spanish to the FDA-483 via mail on March 19, 2010, and also submitted additional responses in English to Observations #1, #12, and #9 on the FDA-483 which were received by FDA on June 1, 3, and 14, 2010, respectively.
Upon further review of the inspectional findings and documentation provided in your firm's responses, we have the following concerns with regard to your low-acid canned food products:
• Your firm failed to provide process information which was deemed necessary by the FDA to determine the adequacy of that process as required by 21 CFR 108.35(c)(3)(ii). Specifically, the original scheduled process for Octopus in Oil processed in (b)(4) manufactured on October 13, 2009 could not be located when requested by the investigator. In addition, the supporting thermal studies provided for this scheduled process filing do not match the actual process for this product/can size. Your response indicates that heat penetration tests and thermal distribution studies will be conducted to validate this particular scheduled process (b)(4) Depending on the outcome of these studies, a revised scheduled process may need to be filed with FDA. All scheduled processes are to be established by qualified persons having expert knowledge of thermal processing and they must specify all critical factors that may affect the scheduled process as required by 21 CFR 113.83.
• Your firm failed to use the mercury-in-glass (MIG) thermometer as the reference instrument for indicating the process temperature of your (b)(4) still retorts as required by 21 CFR 113.40(a)(1). Specifically, your "Produccion Maquinas Cerradoras" processing record for Octopus in Oil in (b)(4) on October 13, 2009 (b)(4) shows no record of MIG readings during the retort (sterilization) process.
• Your firm failed to determine and record the initial temperature of the contents of the containers prior to processing to ensure that the temperature of the product is no lower than the minimum initial temperature specified in the scheduled process as required by 21 CFR 113.87(c). Specifically, your "Produccion Maquinas Cerradoras" processing record for Octopus in Oil in (b)(4) on October 13, 2009 (b)(4) shows no record of initial temperature taken prior to the retort operation. Subsequently, this same production record was not signed as reviewed by a qualified representative of plant management within one working day after the completion of the actual process as required by 21 CFR 113.100(b).
• Your firm failed to record observations of visual closure examinations performed by a qualified person to ensure proper closure as required by 21 CFR 113.60(a). Specifically, observations of visual seam closure examinations were not made for Octopus in Oil processed in (b)(4) on October 13, 2009. Your response included a new Standard Operating Procedure for conducting visual closure examinations; however we would like to review actual processing records that show the implementation of this new procedure.
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 further correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. In addition, responding in English will help to assist us in our review of your documentation. 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: Robyn R. Jones, 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 Ms. Jones at (301) 436-2575 or via email at robyn.jones@fda.hhs.gov.
Sincerely,
/S/
Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
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