FDA EIR - Gress Refrigerated Services, Inc. - May 15, 2019

An FDA inspection of Gress Refrigerated Services, Inc. in Scranton, PA, was conducted from May 13-15, 2019, focusing on Building 2, which handles both human and animal food. The inspection, part of modernized GMP and animal food regulatory oversight, identified two significant observations documented on a Form FDA 483.

The first observation cited the company for failing to hold animal food under conditions that protect against contamination and minimize deterioration, as per 21 CFR 507.27(a). Inspectors found numerous excessively damaged pallets of frozen animal by-products for pet food, with visible contamination from shredded plastic and wood due to compromised shrink wrap and pallets. Management acknowledged the issue, promising corrective actions including employee retraining on forklift operations and pallet handling, and held a meeting with warehouse staff to address these errors.

The second observation stated that the plant's construction did not facilitate proper maintenance and sanitary operations, violating 21 CFR 117.20(b). Specific issues included water pooling from a deteriorating roof, loose-fitting loading dock doors, and gaps in freezer exit door seals, all creating potential contamination routes. Management initiated an investigation into the leaks and committed to sealing or replacing necessary door components.

Both observations were noted as "Not Corrected" at the conclusion of the inspection, indicating that further company actions are required to resolve the identified deficiencies.