FDA 483 - Merck Biodevelopment - October 14, 2022

Merck Biodevelopment - Site Montesquieu received a Form 483 with 10 observations related to significant deficiencies in data integrity, quality assurance oversight, environmental monitoring, deviation investigations, and procedural controls. The inspection revealed issues ranging from inadequate segregation of duties and lack of proper risk assessments to recurring mold contamination and insufficient employee training. These findings indicate a systemic lack of control over critical manufacturing and quality processes for drug substances.