FDA 483 - OSRX Inc. - September 23, 2021

This FDA Form 483 document details observations from an inspection concerning a firm's sterile drug compounding practices. The primary finding relates to the inadequacy of the laminar airflow studies (smoke studies) performed on the ISO 5 Laminar Airflow Workstation.

The studies, conducted in May 2021, were found deficient because they did not accurately represent current aseptic compounding operations. Specifically, they were not performed under dynamic conditions that fully simulate normal operating procedures for sterile drug production.

Two key deficiencies were identified: 1. The smoke studies failed to simulate the entire filling process, including the priming of the pump used to fill vials with the compounded drug product. 2. The studies did not simulate the practice of two operators working together within the ISO 5 Laminar Air Flow Hood during filling, capping, and sealing operations.

These observations indicate a potential gap in the firm's quality system regarding environmental control validation and aseptic process simulation, which could have implications for the sterility assurance of their compounded drug products.