FDA 483 - PF Soins de Sante SRI - October 27, 2023

An FDA inspection conducted at PF Consumer Healthcare Canada ULC in Saint-Laurent, Canada, from October 23-27, 2023, identified significant deficiencies in the firm's quality system. The observations, detailed in an FDA Form 483, indicate that the company's quality control unit did not fully uphold its responsibilities to ensure product quality and safety.

Inspectors observed brown and/or black stains, resembling rust, mold, or product residues, on metal grids in the ceiling of multiple manufacturing rooms where drug products were exposed to the environment. This condition has been present since at least 2022, potentially compromising the sterility and quality of numerous products. The quality control unit failed to adequately investigate a customer complaint regarding an uncharacteristic bitter taste in a product manufactured in one of these rooms, and did not establish appropriate corrective actions.

Furthermore, the inspection revealed a failure to thoroughly investigate unexplained discrepancies, including several customer complaints. These complaints reported issues such as an adverse event (dizziness/headache), product contamination with a worm, and inconsistent or chemical tastes. In many cases, investigations relied solely on visual examination of retain samples, without necessary chemical evaluation. An Out-of-Specification investigation for a product degradant was also found to be insufficient, lacking a thorough assessment of the root cause. The firm must address these observations by submitting comprehensive corrective and preventive actions to ensure compliance with regulatory standards.