Inspections, Compliance, Enforcement, and Criminal Investigations
FRANZESE S.P.A. 4/30/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
APRIL 30, 2014
VIA EXPRESS DELIVERY
Mr. Salvatore M. Franzese
Via Traversa Corso Nuovo N.33
Reference No. 428352
Dear Mr. Franzese:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) facility located at Via Traversa Corso Nuovo N.33, PALMA CAMPANIA, Italy on November 4-5, 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 your firm. We acknowledge receipt of email correspondence from your firm on November 6, 2013; however, the documentation attached to the emails did not specifically address the observations listed on the FDA-483.
As a manufacturer of low-acid canned food (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 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 firm’s filed scheduled process for Red Kidney Beans in Water and Salt (b)(4) identifies a minimum process (b)(4); however, our investigator observed (b)(4) your process records that indicated a process time of (b)(4) for your (b)(4). This process time deviation was observed on process records for the following production dates: February 5, 2013; February 26, 2013; February 28, 2013; March 25, 2013; April 8, 2013; and May 22, 2013. Your firm explained that the process time identified on the filed scheduled process includes that of the entire thermal process (including come up time, thermal process delivery time, and cool down time); however, the critical factor of process time filed with FDA should reflect the actual time required for delivery of the scheduled process. Therefore, your firm needs to revise your scheduled processes accordingly and re-file them with FDA.
In addition, your firm failed to identify process deviations from the scheduled process when critical factors were out of control as required by 21 CFR 113.89. Specifically, in the instances described above, you did not identify the shorter process times as deviations from the scheduled process filed with FDA.
- Your firm failed to ensure that the temperature of the product is no lower than the minimum initial temperature specified in the filed scheduled process as required by 21 CFR 113.87(c). Specifically, your firm’s filed scheduled process for Red Kidney Beans in Water and Salt (b)(4) identifies a (b)(4); however, initial temperature measurements observed on your records during our inspection showed liquid medium (initial temperatures) ranging (b)(4). Your firm explained that you understood the minimum initial temperature to be that of the sterilizer and not of the product. You also stated you would update your filed scheduled processes to reflect your actual process; however, as of this time, we have not received any revised scheduled processes/SIDs.
- Your firm failed to have each retort equipped with at least one temperature-indicating device that accurately indicates the temperature during thermal processing of your (b)(4) as required by 21 CFR 113.40(a)(1). Specifically, on November 4, 2013, our investigator observed that there were no temperature-indicating devices on your firm’s (b)(4).
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 #428352 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