FDA Puts Chinese Manufacturer on Import Alert

FDA sent a warning letter, dated Nov. 30, 2018, to Cao Medical Equipment Co., Ltd. detailing current good manufacturing practice (CGMP) violations agency inspectors observed during an inspection of the company’s Langfang Industrial Zone, Langfang, Hebei facility, which was performed from July 16–20, 2018. Violations found included a failure to perform testing of final drug products and inappropriate use and cleaning of manufacturing areas.

Specifically, the warning letter states that manufacturing areas were exposed to “the outdoor environment where it is exposed to vermin, animal waste, and various contaminants …  In addition, you do not protect your (b)(4) from the ingress and proliferation of objectionable microorganisms.”

According to FDA, the company did not test finished drug products for total aerobic microbial count and objectionable microorganisms prior to release and distribution. The company also failed to test batches for identity and strength of API before release. “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 stated in the letter. Purity, strength, and quality were also not tested in samples of each component, and reliability of component supplier’s test analyses were not properly validated.

Proper process control written procedures were not established, according to FDA. “You have not validated the processes used to manufacture your drug products, you did not define or identify critical process parameters, and you lack an ongoing program for monitoring process controls to ensure stable manufacturing operations and consistent drug quality,” the agency stated.

In the letter, FDA stated that the company’s response was inadequate, and the company continued to ship drugs to the United States after it said it would stop manufacturing and distributing drugs to the US. FDA placed the company on Import Alert 66-40 on November 26, 2018 and recommended the company acquire a CGMP consultant before resuming production.

Source: FDA