FDA 483 - Reliable Biopharmaceutical LLC - February 21, 2020

Reliable Biopharmaceutical LLC, an API manufacturer in Overland, MO, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate investigations and corrective actions, failure to calibrate equipment, deficient personnel training, non-compliance with reference standard procedures, insufficient data integrity controls for computerized systems, and poor building maintenance. These issues indicate a moderate level of non-compliance with GMP regulations.