483
Zhejiang Langhua Pharmaceutical Co. Ltd.FDA 483 - Zhejiang Langhua Pharmaceutical Co. Ltd. - August 30, 2024
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.
Record Details
An FDA inspection of Zhejiang Langhua Pharmaceutical Co. Ltd., an API drug manufacturer, revealed significant deficiencies in laboratory controls and master batch production records. The firm failed to implement scientifically sound water sampling methods and lacked established time limits and detailed production instructions in their batch records, indicating potential quality control issues.
Open in Dashboard
ID · 04398447-8cd1-4445-ba04-2b4ee29ce51e