FDA’s summer scrutiny spotlighted persistent vulnerabilities. Our analysis of 483s released in July reveals three recurring themes at 503B facilities, patterns with relevance for any sterile operation.
Finding I: Aseptic
FDA’s July observation trend revealed a clear pattern: aseptic practices remain a critical vulnerability. Multiple 503B outsourcing facilities faced citations for gowning breaches such as untreated hands, unsanitized materials entering ISO 5 spaces, and poor airflow management during sterile compounding. Even more telling? Environmental monitoring gaps: insufficient viable air/surface sampling, coupled with weak investigations that ignored root causes and trend analysis. These aren’t isolated missteps; they’re systemic red flags for any site handling sterile products. Read More >
