FDA 483 - Pharmaceutics International, Inc. - September 29, 2021

The FDA inspection of Pharmaceutics International, Inc. in Cockeysville, MD, a sterile drug manufacturer, revealed significant and repeat deficiencies across quality control, aseptic processing, and facility maintenance. These issues include failures in thoroughly investigating discrepancies, ensuring data integrity, preventing microbiological contamination, and maintaining proper environmental controls. The findings indicate systemic problems that could impact the quality and safety of manufactured drug products, leading to product recalls.