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  5. PROVITUS Dabrowscy, Malesa S.J. - 07/17/2014
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PROVITUS Dabrowscy, Malesa S.J.

PROVITUS Dabrowscy, Malesa S.J.

United States

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

JUL 17, 2014

Mr. Stanislaw Dabrowski, Owner
Provitus Dabrowscy, Malesa S.J.
U1 Magazynowa 4
18-300 Zambrow
Reference No. 433918
Dear Mr. Dabrowski:
The U.S. Food and Drug Administration (FDA) inspected your acidified and low-acid canned food (LACF) facility located at U1 Magazynowa 4, 18-300 Zambrow, Poland on January 30-31, 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)) 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 www.fda.gov.
Furthermore, our investigator obtained product labeling during the inspection for several or your products. We have reviewed these labels and found violations of the food labeling regulations, 21 CFR Part 101, that cause your products to be misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343).
Your significant violations are as follows:
Food Adulteration Violations:
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). 
However, you do not have a scheduled process on file with FDA for your firm’s products which include, but are not limited to, Sautéed Carrots and Sautéed Wild Mushrooms “Suillus Luteus.” 
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/AcidifiedLACFRegistration/default.htm
2.    Your firm failed to provide FDA with the process and procedure information deemed necessary to determine the adequacy of the scheduled process, as required by 21 CFR 108.35(c)(3)(ii). Specifically, your firm could not provide information which demonstrates adequate heat distribution for products that are processed in your horizontal still sterilizers. At the time of the inspection, your firm stated that you have been processing these products using thermal parameters based on years of experience. You also stated that your firm would be contacting a process authority to aid in conducting a heat distribution and heat penetration study for your products, however, no further information was provided on the status or the results of this study.
3.    Your firm failed to ensure that each retort shall have an accurate temperature-recording device, as required by 21 CFR 113.40(a)(2). Specifically, our investigator observed a temperature-recording device on your horizontal still steam retort; however, this device was not in use. Additionally, photographic evidence was taken to show that your chart recorder was not functioning. When asked about the functionality of your temperature-recording device, your firm responded that the temperature recording device was not functional and has not been in use for a period of time.
4.    Your firm failed to ensure that each retort shall be equipped with an automatic steam controller to maintain the retort temperature, as required by 21 CFR 113.40(a)(4). Specifically, our investigator observed that your firm’s (b)(4) was not equipped with automatic steam controllers. Furthermore, our investigator observed that your firm’s retorts are each equipped with (b)(4). Throughout product production, an operator stands by the retort for the entirety of the thermal process and relies upon the (b)(4). The operator would then manually adjust the retort in the event of a temperature drop. The practice of relying on (b)(4) is not an adequate practice to achieve a safe thermal process.
5.    Your firm failed to ensure that the timing devices used in recording thermal process time information shall be accurate to the extent needed to ensure that the processing time and venting time specified in the scheduled process are achieved, as required by 21 CFR 113.87(d). Specifically, our investigator observed your firm’s retort operator look at his (b)(4). The practice of using a (b)(4) is not considered adequate for timing purposes.
Labeling Violations:
1.    Your Marinated Yellow Pepper product is misbranded within the meaning of section 403(q) in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. The declared serving size for this product is 100 g. However, the serving size must be determined based on the Reference Amount Customarily Consumed (RACC) [21 CFR 101.12(b)]. The RACC for vegetables without sauce, canned in liquid, is 130 g. The declared serving size is less than the RACC; therefore, all nutrition facts information is incorrect for each nutrient. Additionally, the serving declaration is not expressed in common household measure [21 CFR 101.9(b)(5)]. A sample serving size statement for this product is _ cup(s) (130 g).
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 #99-38. This alert can be found on FDA’s web site at: 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: 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 #433918 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.
Acting Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition
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