Inspections, Compliance, Enforcement, and Criminal Investigations
Alcaparras Luxeapers SLU 4/11/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD|
April 11, 2012
Mr. Jose Manuel Cordoba Garcia-Malea
Alcaparras Luxeapers SLU
Autovia A-92 Salida 352
Reference No.: 291157
Dear Mr. Garcia-Malea:
FDA inspected your facility Alcaparras Luxeapers SLU located at Autovia A-92 Salida 352, Nacimiento, Spain on January 30-31, 2012. During that inspection, we found that your firm had serious deviations from the acidified food regulations. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108), and Part 114, Acidified Foods (21 CFR 114). As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR Part 114 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.250), for imported products, in lieu of issuing an order of determination that a permit is required before products from such commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. In addition, violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR Part 114 renders your acidified garlic cloves in vinegar and onions in brine adulterated within the meaning of Section 402(a)(4) of the Act (21 U.S.C. 342(a)(4)). 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 did not file information on the scheduled process for the acidified foods garlic and cloves and onions in brine as required by 21 CFR 108.25(c)(2). Your firm manufactures other products which may also be acidified foods, including garlic in oil, gherkins, and piri piri. Your firm is also responsible for determining whether any of these or any other products that you manufacture are acidified foods subject to the requirements of 21 CFR 108 and 114.
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 there-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.
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 acidified food regulations (21 CFR Part 108 and 114) is Import Alert #99-04. This alert can be found on FDA's web site at:
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 acidified food regulations (21 CFR Part 108 and 114), 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 (240) 402-2057 or via email at firstname.lastname@example.org.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition