Regulatory Focus™ > News Articles > 12 > FDA Warns Chinese Manufacturer Over Product Testing Failures

FDA Warns Chinese Manufacturer Over Product Testing Failures

Posted 20 December 2018 | By Ana Mulero 

FDA Warns Chinese Manufacturer Over Product Testing Failures

China-based Cao Medical Equipment drew a US Food and Drug Administration (FDA) warning letter after it continued to ship adulterated drugs despite promising to “immediately stop.” 
The warning letter cites significant violations of good manufacturing practices at a facility in Hebei, China that resulted in adulterated drug products. It comes after the firm failed to ease FDA’s concerns in its response to a July Form 483. The firm was placed on import alert last month. 
An FDA review of import records found the firm “continued to ship drugs to the United States despite stating” in its August response letter that it would “immediately stop manufacturing and distributing drugs” into the US, according to the warning letter. The firm committed to recalling all drug products in the US market just last month after discussing the violations with FDA. 
FDA’s site visit in July revealed product testing failures. The firm had failed to test all drug product batches for total aerobic microbial counts, objectionable microorganisms and active ingredients. “Without this testing, you do not have scientific evidence that all drug product batches you manufactured meet their established specifications prior to release,” FDA said. 
Active pharmaceutical ingredients and other components used by the firm for its drug product manufacturing had not been tested to determine their identities, purities and strengths either. 
Cao Medical Equipment also failed to analyze lots of glycerin raw material from a supplier for the potential presence of diethylene glycol (DEG) and ethylene glycol prior to releasing its glycerin for other manufacturers to use. “DEG contamination has resulted in various lethal poisoning incidents in humans worldwide,” FDA continues to stress in warning letters, including this one and a warning letter issued to an Irish Europharma Concepts facility earlier this year. 
FDA further observed the Cao Medical Equipment plant was “open to the outdoor environment where it is exposed to vermin, animal waste and various contaminants.” The firm was also cited for failing to validate drug product manufacturing processes as well as a lack of critical process parameters and an ongoing program to monitor process controls, among other nonconformities. 
The firm will have to implement comprehensive corrective actions, including lab testing and process validation, if it intends to lift the import alert to start manufacturing for and shipping to the US again, according to the warning letter. Retaining a qualified consultant to conduct a comprehensive audit of the firm’s whole operation is “strongly recommended” by FDA as well. 
CAO Medical Equipment Co., Ltd. 11/30/18


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.