FDA 483 - Encompass Pharmaceutical Services Inc. - June 03, 2022

An FDA inspection of Encompass Pharmaceutical Services Inc., a laboratory in Peachtree Corners, GA, revealed significant deficiencies in their quality control systems. The firm failed to thoroughly investigate discrepancies, lacked adequate stability data to support drug product expiration dates, and exhibited poor controls over computer systems. These issues indicate a lack of robust procedures for ensuring product quality and data integrity.