| Public Health Service Food and Drug Administration |
| College Park, MD |
Department of Health and Human ServicesWARNING LETTER
MAY 27, 2010
Mr. Alejandro Martinez Campo
General Manager
Industrias Alimentarias de Navarra, S.A.U.
Poligono Penalpons s/n 31,330
Villafranco Navarra, Spain
Dear Mr. Campo:
FDA inspected your low-acid canned food facility located at Barrio De La Estacion s/n, 10730 Casas del Monte, Caceres, Spain, on February 18-22, 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, canned black olives, 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 to the FDA-483 via email on February 25, 2010.
Upon further review of the inspectional findings and documentation provided in your February 25, 2010 response, we have the following concerns with regard to your low-acid canned food products:
• Your firm failed to determine and record the initial temperature of the contents of the black olives in (b)(4) 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, on February 18, 2010, our investigator observed no initial temperatures being recorded prior to the processing of black olives in (b)(4) In addition, your firm's thermal processing records show that no initial temperatures were recorded prior to processing black olives in December 23, 2009, respectively. Subsequently, these same records failed to contain other critical factors identified in your scheduled process, such actual processing times and the Mercury-in-glass temperatures, as required by 21 CFR 113.100(a)(7). Your firm's response included a modified blank template record to be used to record processing data including initial temperatures, size of containers, and processing times; however, we would like to review completed processing records utilizing this newly modified record template.
• Your firm failed to properly identify and handle temperature process deviations that occur during the thermal processing of canned black olives in your (b)(4) retorts as required by 21 CFR 113.89. Specifically, on February 18, 2010, our investigator observed the retort operation of black olives in (b)(4) being processed at (b)(4) where the scheduled process identified a processing temperature of (b)(4) Our investigator observed no corrective action taken when this process deviation occurred. Additionally, during further record review, a similar process deviation was found for (b)(4) black olives processed on November 12, 2009 in (b)(4). Your firm's temperature recording chart records for Retort #2 show that the temperature dropped to (b)(4) during one run and ranged from (b)(4) during other runs. The scheduled process for black olives in (b)(4) identifies a processing temperature of (b)(4). According to your firm's management, your method of handling these types of process deviations is to (b)(4). In addition to documenting the length of the extended cook time for these lots, the Fo values should be calculated, and these corrective actions should be documented and reviewed by your process authority. We acknowledge that your firm has provided evidence of creating a separate file detailing these process deviations and the corrective actions taken in accordance with 21 CFR 113.89, however, we would like to review actual process deviation records to ascertain how your firm handled the corrective actions.
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: 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/
Donald A. Kautter, Jr.
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
cc:
Mr. Fernando Fernandez Jimenez
Plant Manager
Industrias Alimentarias de Navarra, S.A.U.
Barrio de la Estacion, s/n.
10730 Casas del Monte
Caceres, Spain
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