FDA 483 - Pillar5 Pharma Inc. - December 15, 2023

Pillar5 Pharma Inc., a manufacturer of sterile OTC drug products, received a Form 483 citing significant deficiencies. Observations included inadequate validation of aseptic processes, failures in investigating microbial excursions and consumer complaints, and deficiencies in their supplier qualification program for container/closure systems. These issues indicate a lack of robust quality control and process validation for sterile drug manufacturing.