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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Smak Sp. z o.o. 5/15/12

  

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

Public Health Service
Food and Drug Administration
 

College Park, MD

MAY 15, 2012

WARNING LETTER

VIA OVERNIGHT DELIVERY

Mr. Tomasz Pruszynski
Production Director
Smak Sp. z o.o. c/o
Prymat Sp. z o.o.
Chlebowa 14
44-337 Jastrzebie Zdroj
Poland

Reference No.: 301958

Dear Mr. Pruszynski:

The U.S. Food and Drug Administration (FDA) inspected your acidified food facility, Smak Sp. z o.o., located at ul. Pukowca St. 93A, 44-240 Zory, Poland, on January 26-27, 2012. During that inspection, we found that your firm had serious deviations from the acidified food regulations. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108) and Part 114, Acidified Foods (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 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 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from such 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. In addition, violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR Part 114 renders your 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 and the acidified food regulations through links in FDA's home page at http://www.fda.gov.

This inspection resulted in FDA's issuance of an FDA-483, Inspectional Observations, listing the deviation found at your firm at the conclusion of the inspection. Your firm provided a response to the FDA-483 dated February 14, 2012; however, upon review of the inspectional findings, information provided in your firm's response, and the filed scheduled processes you currently have on file in the FDA LACF Online Database, we have the following remaining significant concern with regard to your acidified food products:

As a commercial processor engaged in the processing of acidified foods you must provide FDA information on the scheduled processes including, as necessary, conditions for heat processing and control of pH for each acidified food in each container size, not later than 60 days after registration and before packing any new product, as required by 21 CFR 108.25(c)(2). Specifically, your firm intentionally made changes to the thermal processing method of all your acidified food products and failed to submit revised scheduled process filings to FDA before manufacturing and shipping such acidified food products as red beets grated, pickled mushrooms, sauerkraut, sauerkraut with carrots, and pickled cucumbers.

Your firm currently has (b)(4) active acidified food processes on file (b)(4) as the thermal method. Our inspection revealed that you (b)(4) and should be deleted from the LACF Oneline Database. We acknowledge that your firm submitted (b)(4) process filings on February 10, 2012; however, these filings were returned as they were missing critical processing information. If your firm intends to manufacture acidified food products for the U.S., you must have each of your revised scheduled processes established by a qualified person who has expert knowledge in the processing of acidified foods, in accordance with 21 CFR 114.83, before submitting these revised process filings to FDA.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to further correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen working days, you should explain the reason for your delay and state when you will correct any remaining violations.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported low-acid canned food 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 acidified food regulations (21 CFR Part 108 and 114) 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 you firm operates in compliance with the Act, the acidified food regulations (21 CFR Part 108 and 114), and the Current Good Manufacturing Practice regulation (21 CFR Part 110), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

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 the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). 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 send your reply to the U.S. Food and Drug Administration, Attention: Robyn R. Jones, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. Jones at (240) 402-2575 or via email at robyn.jones@fda.hhs.gov.

Sincerely,

/s/

Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition