- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
JUL 17, 2014
VIA EXPRESS DELIVERY
Bogumil Rajda, Owner
U1. Starowiejska 41
Reference No. 433927
Dear Mr. Rajda:
The U.S. Food and Drug Administration (FDA) inspected your acidified and low-acid canned food (LACF) facility located at U1 Adama Mickiewicza 26, Sucha Beskidzka, Poland on January 20-21, 2014. 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)); Acidified Foods regulation (21 CFR 114); 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 acknowledge receipt of your response received via email dated January 27, 2014, which included a document 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 LACF and acidified food products intended for export to the United States, you are required to comply with the Act and the federal regulations relating to the processing of low-acid foods packaged in hermetically sealed containers and acidified food products. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25 and 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR Parts 113 and 114. Regulations specific to the processing of LACF and acidified food products are described in 21 CFR 108, 21 CFR 113, and 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, 21 CFR 108.35, 21 CFR 113, and 21 CFR 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 108.25(j) and 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 108.25, 21 CFR 108.35,21 CFR 113, and 21 CFR 114 renders your LACF and acidified food 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, Acidified regulations, and LACF regulations through links in FDA’s home page at www.fda.gov
Your significant violations are as follows:
1. 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). Specifically, you do not have scheduled processes on file for your firm’s (b)(4) products.
We acknowledge that your firm submitted a scheduled process for (b)(4) products to FDA on May 28, 2014. However, based on the incomplete information submitted with your process filing, your filings were returned on July 2, 2014. Therefore, you currently do not have scheduled processes on file with FDA for these products and process filings for these products must be resubmitted.
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: www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedL…
2. Your firm failed to ensure the use of a potentiometer method to measure pH when the finished equilibrium pH is above 4.0, as required by 21 CFR 114.80(a)(2). Specifically, our investigator observed that the scheduled process for your (b)(4), identifies a the finished equilibrium pH (b)(4); however, your firm is not using a potentiometric method to measure the finished equilibrium pH of this product.
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 acidified and 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 and acidified food regulations (21 CFR 108, 113, and 114) is Import Alert #99-38. This alert can be found on FDA’s web site at: www.accessdata.fda.gov/cms_ia/ialist.html.
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), Acidified regulations (21 CFR 108 and 114), 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: Asha Dwarka, 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. Please reference #433927 on any submissions and within the subject line of any emails to us. You may also contact Asha Dwarka via email at Asha.Dwarka@fda.hhs.gov if you have any questions about this letter.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition