FDA 483 - Hybio Pharmaceutical Co. Ltd (Site 1) - June 26, 2015
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · b007a6a1-03fa-49f9-ae16-196878373dfe