FDA 483 - MasterPharm LLC - January 30, 2017

This FDA Form 483 was issued to MasterPharm LLC, a producer of sterile and non-sterile drug products located at 115-02 Liberty Avenue, Richmond Hill, NY 11419. The inspection was conducted from January 17-20, 23, and 30, 2017, and the report was issued on January 30, 2017, to Mr. Stephen S. Laddy, CEO.

Two observations were noted: 1. **Failure to conduct adequate aseptic process simulation (APS):** * Vials produced from the APS were not submitted for sterility testing in a timely manner. * Not all vials produced from the APS were submitted for sterility testing. 2. **Failure to depyrogenate stoppers:** * Stoppers used in the production of sterile compounding products were not depyrogenated.

These observations indicate deficiencies in MasterPharm LLC's quality system and manufacturing processes, specifically concerning the sterility assurance of their sterile drug products. The document serves as an inspectional observation and does not represent a final agency determination of compliance.