FDA 483 - PAI Holdings, LLC. dba Pharmaceutical Associates Inc - August 02, 2023

PAI Holdings, LLC. dba Pharmaceutical Associates, Inc in Greenville, SC, was cited for significant deficiencies during an FDA inspection from July 24 to August 2, 2023. Observations included failures in equipment calibration, work order initiation for identified issues, and concurrent documentation practices. Additionally, the firm lacked adequate written procedures for cleaning and maintenance schedules, leading to conditions like rust on manufacturing equipment.