FDA Issues Warning to Chinese Drugmaker
The FDA hit Chinese manufacturer CAO Medical Equipment with a warning letter citing drug and API testing violations at its Langfang, Hebei facility.
During a July 16 to 20 inspection, the agency found that the firm didn’t test all of its finished drug products for aerobic microbial counts. It also neglected to test the identity and strength of each batch of APIs.
“Without this testing, you do not have scientific evidence that all drug product batches you manufactured meet their established specifications prior to release,” the agency said.