FDA 483 - Asept Pak Inc. - December 20, 2019

Asept Pak Inc. in Malone, NY, was cited for significant deficiencies during an FDA inspection from December 11-20, 2019. The observations highlight critical issues across manufacturing process validation, aseptic processing controls, product stability data, equipment maintenance, and quality control unit adherence. These findings indicate a severe lack of control over the manufacturing environment and processes for their sterile infant analgesic products, raising concerns about product quality and sterility.