Inspections and Audits

Chinese API Manufacturer Cited for Quality Shortcomings

The FDA issued a warning letter to Zhuhai United Laboratories, an active pharmaceutical ingredient firm based in Zhuhai, China, taking the facility to task for failure to investigate out-of-specification results and correct critical CGMP deviations. Read More

Chinese API Manufacturer Draws FDA Warning

The FDA placed Sichuan-based drugmaker Sichuan Friendly on an import alert after an October inspection of its facility in Neijiang City revealed stability and manufacturing issues with active pharmaceutical ingredients shipped to the U.S. Read More

Chinese API Manufacturer Draws FDA Warning

The FDA placed Sichuan-based drugmaker Sichuan Friendly on an import alert after an October inspection of its facility in Neijiang City revealed stability and manufacturing issues with active pharmaceutical ingredients shipped to the U.S. Read More