FDA WARNING_LETTER - FSS, Inc. - January 09, 2015

The FDA inspected FSS, Inc. dba Food Service Specialties in Red Wing, Minnesota, from December 2014 to January 2015, identifying significant deviations from Low-Acid Canned Foods (LACF) regulations (21 CFR Part 113), Acidified Foods regulations (21 CFR Part 114), and Current Good Manufacturing Practices (21 CFR Part 110).

For LACF products, violations included failure to process according to scheduled processes (e.g., incorrect viscosity/headspace temperature measurements, exceeding maximum fill weights), inadequate frequency of critical factor measurements (e.g., rotation speed not recorded), improper initial temperature determination, lack of heat-sensitive indicators on retorted units, failure to record cold water vacuum tests for cappers, insufficient frequency of closing machine performance checks (low security values), inadequate calibration records for temperature-indicating devices, and failure to record process deviations and corrective actions.

For Acidified Foods, violations included manufacturing not in accordance with the scheduled process (e.g., incorrect jar temperature, process temperature discrepancies, unvalidated flow rate for residence time) and failure to prevent contamination (e.g., non-functioning air blower for glass jars, inadequate response to broken jars on conveyor).

The firm's responses to the FDA-483 were deemed inadequate, lacking documented evidence of corrective actions, particularly regarding process deviation handling and product disposition. The FDA noted the firm suspended LACF operations