FDA 483 - Thermo Pac LLC - June 03, 2011

During an FDA inspection from May 23 to June 3, 2011, Thermo Pac LLC, an Acidified and Low Acid Canned Food Manufacturer located at 1609 Stone Ridge Dr, Stone Mountain, GA, received eight observations.

Observation 1 noted the firm's failure to provide the FDA with scheduled processes for any new acidified food products, including Simply Thick thickening gel, and lacked documentation that operating processes were established by a competent Processing Authority.

Observation 2 cited a similar failure to provide scheduled processes for low-acid canned cheese products.

Observation 3 stated that Simply Thick thickening gel, an acidified food with a target pH of [pH not specified], was cold-filled without a thermal process, and no scientific documentation excluded it from needing one, indicating insufficient thermal processing to destroy microorganisms.

Observation 4 highlighted inadequate chemical testing for sanitation failures and contamination. The firm's allergen monitoring program was insufficient, as a positive allergen swab on a kettle sweep on April 10, 2011, led only to cleaning the sweep, not the entire kettle, despite multiple subsequent positive results on the sweep. Additionally, the firm only tested for peanut proteins despite using other recognized allergens.

Observation 5 detailed a failure to maintain equipment and utensils in an acceptable condition, with protein residual testing showing high failure rates (64.28% in August 2010, 80.77% in September,