FDA Issues Warning Letter to Polish Pickle Company; May Refuse Admission to U.S.
The Food and Drug Administration found serious deviations from the acidified food regulations during an inspection of the Zory, Poland facility of Polish Company Smak Sp. z o.o., FDA said in a warning letter issued May 15. According to the warning letter, Smak intentionally made changes to the thermal processing method of its 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. FDA acknowledged receipt of revised process filings in February 2012, but said that these filings were returned as inadequate as they were missing critical processing information.
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FDA said Smak should respond in writing within fifteen (15) working days from receipt of this warning letter. If Smak does not respond, or such response is inadequate, FDA said it may take further action, such as refusal of admission of Smak’s imported low-acid canned food products, 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.)