FDA Warns Chinese API Supplier for Deficient COAs, Quality
The FDA issued a warning letter to an active pharmaceutical ingredient distributor in Chongqing southwestern China for serious problems with quality and certificates of analysis.
The agency inspected Yino’s facility from March 18-22 and found significant GMP violations for APIs it relabeled and distributed to other facilities for eventual sale in the U.S. Specifically, the COAs it generated for multiple lots of injectable-grade drugs lacked the name and address of the original manufacturer.
In addition, COAs the firm created for several lots of API didn’t include a signature and date from an authorized quality unit employee.