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WARNING LETTER

Azienda Agricola Paul Cappelli MARCS-CMS 491520 — Apr 20, 2016

Azienda Agricola Paul Cappelli - 491520 - 04/20/2016


Recipient:
Recipient Name
Mr. Paul Cappelli
Azienda Agricola Paul Cappelli

Via Appia Traiana 11

Terllizzi
Italy

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 20740 

 

APR 20 2016
 
WARNING LETTER

VIA EXPRESS DELIVERY

Mr. Paul Cappelli, Owner
Azienda Agricola Paul Cappelli
Via Appia Traiana 11
Terllizzi, Italy
 
Reference No.: #491520
 
Dear Mr. Cappelli:
 
The U.S. Food and Drug Administration (FDA) inspected your acidified food (AF) facility Azienda Agricola Paul Cappelli on December 9 - 10, 2015. 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 Part 108) and the Acidified Foods regulation (21 CFR Part 114). 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 your response received via email dated December 17, 2015, which included documentation describing corrections to the observations of concern noted on the form FDA-483. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
 
As a manufacturer of AF products, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of the acidified food products you export to the United States. These regulations are described in 21 CFR Part 108, Emergency Permit Control and 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control (21 U.S.C. § 344). As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR Part 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 Part 108.25U), 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. Consequently, your violations of the mandatory requirements set forth in 21 CFR Parts 1 08 and 114 render your AF 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 acidified foods regulations through links in FDA's home page at www.fda.gov.
 
Your significant violations are as follows:
 
1.    As a commercial processor in the thermal processing of acidified foods 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 conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR Part 108.25(c)(2). Specifically, your firm failed to file scheduled processes with FDA for your Red Onion Jam, Popo (hot chili salsa), and Pepper Jam products.
 
Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). More information on registration and filing can be found in the publication "Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 254le, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format" available at:
 
Your firm's response indicated you were in the process of testing your AF products for water activity and pH and seeking expert advice on filing scheduled processes. We acknowledge that your firm registered with FDA as an AF processor and obtained a Food Canning Establishment (FCE) number; however, to date, no scheduled processes have been filed for your firm’s AF products.
 
2.    Your firm failed to have plant personnel involved in acidification, pH control, heat treatment, or other critical factors of the operation under the operating supervision of a person who has attended a Better Process Control School approved by the Commissioner as required by 21 CFR Part 108.25(f). Your firm's response stated that your HACCP coordinator registered for a FDA approved course through the University of California; however, your response did not indicate when this training would be completed; and if this person will be the operating supervisor of all operators of acidified food processing and packaging systems for products being shipped to the US.
 
You should respond in writing within 15 working days from your receipt of this letter. Your request should outline the specific steps you are taking to correct the deviation. More specifically, your request should include documentation that reflects the changes you made, such as a copy of your filed scheduled processes, five (5) consecutive days of completed monitoring records (i.e., records for the production of five (5) production date codes of the products), and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Submission of the information in English will assist in our review. If you cannot complete all corrections within 15 days, you should explain the reason for the 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 AF 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 and acidified food regulations (21 CFR Parts 108, 113 and 114) is Import Alert #99-37. This alert can be found on FDA's web site at: _1131.htmlhttp://www.accessdata.fda.gov/cms_ia/importalert
 
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the acidified food regulations (21 CFR Parts 108 and 114) and the Good Manufacturing Practice regulation (21 CFR Part 11 0). 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 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 there-inspection and assessing and collecting the re-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. Please consider providing a copy of this letter to your U.S. Agent.
 
Please send your reply to the Food and Drug Administration, Attention: Donald Greaves, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may send any information related to this case and/or any questions you may have regarding this letter to Mr. Greaves via email at: Donald.Greaves@fda.bbs.gov.
 
Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition

 

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