Inspections, Compliance, Enforcement, and Criminal Investigations
Pancrazio S.P.A. 4/18/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
April 18, 2014
VIA EXPRESS DELIVERY
Mr. Antonio Pancrazio, President/Director
Via Angeloni, No 1 – Zona Industriale
Cava Dei Tirreni,
Reference No. 427974
Dear Mr. Pancrazio:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) facility located at Via Angeloni, No 1 – Zona Industriale, Cava Dei Tirreni, Italy on October 30-31, 2013. During that inspection, we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at the firm. We have not received any correspondence from your firm in response to the FDA-483 indicating that you have corrected the problems.
As a manufacturer of LACF products intended for export to the United States, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act) and all applicable federal regulations. Regulations specific to the processing of LACF products are described in 21 CFR 108 and 21 CFR 113. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.35 and 21 CFR 113 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 108.35(k), for imported products, in lieu of issuing an order of determination that a permit is required before products from a 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. Violation of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR 113 renders your LACF products 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 LACF regulations through links in FDA’s home page at http://www.fda.gov.
Your significant violations are as follows:
- Your firm failed to obtain substantiation by a qualified scientific authority as to the adequacy of any intentional change in a previously filed scheduled process as required by 21 CFR 108.35(c)(2)(ii). Specifically, your firm replaced your (b)(4) in May 2012 with new (b)(4) (identified as 1, 2, 3, 4, and 5) and failed to conduct new heat penetration and heat distribution studies to establish new processes for products thermally processed in these new retorts. Products include, but are not limited to the following: Chick Beans in Water & Salt (b)(4), Kidney Beans in Water & Salt (b)(4), and Lentils in Water & Salt ((b)(4). Your firm, in conjunction with your Process Authority, needs to conduct new heat penetration and heat distribution studies in these retorts and submit revised scheduled processes for each product to FDA.
- As a commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including but not limited to the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each such low-acid food in each container size, to comply with 21 CFR 108.35(c)(2). However, you have not filed a scheduled process with FDA for your firm’s Mixed Beans in 400 gram cans.
Scheduled process information for LACF products must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/default.htm
- Your firm failed to process each low-acid canned food in conformity with at least the scheduled process as required by 21 CFR 108.35(c)(3)(i). Specifically, your scheduled process filing for Chick Beans in Water & Salt in cans (b)(4) identifies a minimum process time of (b)(4); however, your process records for the following days indicates a sterilization temperature of (b)(4) that is maintained for (b)(4): June 11, 2013, June 25, 2013, October 16, 2013, October 24, 2013, and October 28, 2013. Your firm explained that the process time identified on the scheduled process includes that of the entire thermal process (including come up time, thermal process delivery time, and cool down time); however, the critical factors on the process filings should reflect the actual process and need to be re-filed.
- Your firm failed to accurately determine and record the initial temperature of the contents of containers 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 firm does not measure and document the critical factor of initial temperature of the product as evidenced by record review of lots of Chick Beans in Water & Salt in cans (b)(4) processed on October 24, 2013.
- Your firm failed to have a qualified representative of plant management review processing and production records for completeness before shipment or release into distribution as required by 21 CFR 113.100(b). Specifically, review of your firm’s processing records from the following dates indicated that these processing records were not signed or dated as being reviewed: June 11, 2013, June 25, 2013, October 16, 2013, October 24, 2013, and October 28, 2013. The processing records reviewed included autoclave sterilization control, fill weight, temperature data tables, production control records and container closure records.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. Responding in English will help to assist us in our review of your documentation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported LACF 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 LACF regulations (21 CFR 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 facility operates in compliance with the Act and all applicable regulations, including the LACF regulations (21 CFR 108 and 113) and the current Good Manufacturing Practices regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additionally, 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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the U.S. Food and Drug Administration, Attention: Robyn R. Jones, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Robyn.Jones@fda.hhs.gov. Please reference #427974 on any submissions and within the subject line of any emails to us. You may also contact Robyn R. Jones at (240) 402-2575 or email if you have any questions about this letter.
Office of Compliance
Center for Food Safety
and Applied Nutrition