FDA 483 - Pharmaceutics International Inc - May 22, 2015

An FDA inspection of Pharmaceutics International Inc. in Hunt Valley, MD, revealed significant deficiencies across its operations. The firm lacked adequate written procedures for production and process controls, failed to properly maintain equipment leading to contamination, and conducted insufficient investigations into out-of-specification results and product defects. These issues indicate a systemic failure to ensure drug product quality and prevent the recurrence of critical manufacturing problems.