FDA 483 - Hybio Pharmaceutical Co. Ltd (Site 1)

Hybio Pharmaceuticals Co. Ltd. in Shenzhen, China, an API manufacturer, was cited for significant deficiencies across its manufacturing operations. Observations included unvalidated in-process analytical methods and inadequate protective apparel practices by operators, leading to potential product contamination. Additionally, poor air handling system configuration and deficient equipment cleaning procedures for laminar flow hoods were noted, both posing cross-contamination risks.