FDA 483 - Pharmaceutics International Inc - December 06, 2024

Pharmaceutics International Inc in Hunt Valley, MD, was inspected and received a Form 483 with four observations, two of which were repeat observations. The inspection revealed deficiencies in equipment cleaning validation, supplier qualification for API microbiological testing, instrument calibration procedures for HPLC systems, and overall equipment qualification and control. These issues indicate significant concerns regarding the firm's quality control and manufacturing processes.