FDA 483 - Pillar5 Pharma Inc. - February 21, 2020

Pillar5 Pharma Inc. in Arnprior, Ontario, was cited by the FDA for failing to establish adequate procedures to prevent microbiological contamination of sterile drug products. The inspection revealed deficiencies in the media fill program's simulation of routine interventions and a lack of required cleaning protocols for aseptic processing interventions. These findings indicate significant concerns regarding the sterility assurance of their manufactured products.