FDA 483 - Pharmasol Corporation - July 16, 2015

Pharmasol Corporation in South Easton, MA, was cited for numerous deficiencies across its laboratory, production, and quality systems during an FDA inspection. Key issues include inadequate computer controls and data integrity, unvalidated test methods, incomplete laboratory records, and a lack of proper equipment calibration and process validation. The firm also failed to conduct thorough investigations into discrepancies and exhibited an inadequate quality control unit and employee training program, indicating systemic failures in cGMP compliance.