FDA WARNING_LETTER - Smak Sp. z o.o. - January 27, 2012

On January 26-27, 2012, the FDA inspected Smak Sp. z o.o.'s acidified food facility in Zory, Poland, identifying serious deviations from 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods). The inspection resulted in an FDA-483, to which Smak Sp. z o.o. responded on February 14, 2012.

The primary concern is the firm's failure to submit revised scheduled process filings to the FDA after intentionally changing the thermal processing method for acidified products like red beets, pickled mushrooms, sauerkraut, sauerkraut with carrots, and pickled cucumbers, as required by 21 CFR 108.25(c)(2). The firm's current filings list an outdated thermal method that should be deleted. Although Smak Sp. z o.o. submitted new filings on February 10, 2012, they were returned due to missing critical information.

The FDA requires that all revised scheduled processes be established by a qualified person per 21 CFR 114.83 before submission. Failure to comply could lead to refusal of admission of products into the U.S. under Section 801 of the Act (21 U.S.C. 381), including detention without physical examination (DWPE) via Import Alerts like #