The FDA cited a combination drug-device product manufacturer in China for serious testing failures and other violations uncovered in an inspection of its facility northwest of Shanghai.
Jiangsu Excellence Medical Supplies failed to test the identity of a drug component to make sure it conformed to written specifications, choosing instead to accept the supplier’s analysis without establishing the supplier’s reliability.
FDA investigators also found live spiders and cockroaches in the warehouse used to receive and hold drug product components. The warehouse doors had gaps that allowed the pests to access other areas of the facility, according to the Form 483 report.
The company lacked an appropriate sampling and testing plan to confirm drug batches met identity, quality and purity standards.