FDA 483 - TAIWAN BIOTECH CO., LTD. - September 20, 2022
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.
An FDA inspection of TAIWAN BIOTECH CO., LTD., a sterile drug manufacturer in Taoyuan City, Taiwan, revealed significant deficiencies in its quality control unit. The firm was cited for issues including unqualified vendors, non-contemporaneous record-keeping, an inadequate CAPA system, and poor management of incubators. Additionally, the inspection found that stability testing results were not properly used to determine storage conditions and expiration dates for its sterile drug products.
- Office
- Office of Partnerships
- Person
ID · ab6f60ca-11ef-48f9-8682-6529304218d6