FDA WARNING_LETTER - AGRO-SERWIS - January 21, 2014

On January 20-21, 2014, the FDA inspected Agro-Serwis's acidified and low-acid canned food (LACF) facility in Sucha Beskidzka, Poland, identifying serious deviations from 21 CFR 108 (Emergency Permit Control), 21 CFR 114 (Acidified Foods), and 21 CFR 113 (Thermally Processed Low-Acid Foods). An FDA-483 was issued, and the firm's January 27, 2014, response was deemed inadequate.

Key violations include: 1. Failure to provide scheduled processes for (b)(4) products to FDA, as required by 21 CFR 108.35(c)(2). Previous submissions were incomplete and returned. 2. Failure to use a potentiometric method to measure the finished equilibrium pH for (b)(4) products, despite the scheduled process identifying a finished equilibrium pH above 4.0, violating 21 CFR 114.80(a)(2).

These violations render the firm's LACF and acidified food products adulterated under Section 402(a)(4) of the Act. The FDA may refuse admission of products under Section 801 of the Act, including detention without physical examination (DWPE) via Import Alerts (e.g., Import Alert #9