Zhejiang Lepu Pharmaceutical Co., Ltd.December 7, 2018

FDA 483 - Zhejiang Lepu Pharmaceutical Co., Ltd. - December 07, 2018

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

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.

Explore Zhejiang Lepu Pharmaceutical Co., Ltd.

Record Details

Zhejiang Lepu Pharmaceutical Co., Ltd. in Taizhou City, China, was inspected by the FDA from December 3-7, 2018. The inspection revealed significant deficiencies in laboratory controls, specifically regarding the validation of test procedures for Active Pharmaceutical Ingredients (API). Additionally, the firm failed to store drug products under appropriate temperature conditions, potentially affecting their quality.

Company: Zhejiang Lepu Pharmaceutical Co., Ltd.
Inspection Date: December 7, 2018
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Gam S. Zamil (issuing_officer)

Open in Dashboard

ID · df3d9da8-596e-42a2-8bae-17bf67ebca4d