FDA 483 - Pharmascience Inc. - February 13, 2024

An FDA inspection of Pharmascience Inc., conducted from February 5-13, 2024, identified several critical observations related to the manufacturing and quality control of sterile and non-sterile drug products. The findings, documented in a Form FDA 483, indicate failures to adhere to essential regulatory requirements.

Key issues included the company's inability to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results. Specifically, a confirmed sterility OOS for a drug product lot lacked a proven root cause, yet other associated lots were released without adequate assurance of sterility. Similarly, customer complaints concerning particulates in injectable products and product usability were closed without identifying root causes or implementing corrective measures. The firm also inadequately handled OOS results for raw material testing, releasing materials into products without scientific justification for compliance.

Further observations noted deficient procedures for preventing microbiological contamination in sterile drug product manufacturing, particularly concerning environmental monitoring practices in clean rooms. Lastly, the inspection revealed that Pharmascience Inc. failed to follow its own written stability testing program, resulting in significant delays in testing numerous product stability samples.

Pharmascience Inc. is expected to promptly address these observations by conducting comprehensive investigations, determining definitive root causes, and implementing robust corrective and preventive actions to ensure product quality, safety, and regulatory compliance.