A Chinese CMO that produces sterile drugs has been slapped with an FDA warning letter after a preapproval inspection found serious issues with its aseptic processes.
The FDA issued the letter to Zhuhai United Laboratories' drug manufacturing facility in Zhuhai, China, after an inspection in September 2017. The plant makes both sterile injectables and other APIs and intermediates.
Among other issues, the FDA said it found “examples of incomplete data relating to the sterile manufacturing operations evaluated as part of our pre-approval inspection.” For instance, the company failed to maintain electronic data documenting decontamination cycles for the grade A area of the workshop where it aseptically manufactures sterile powders. Inspectors found that Zhuhai United Laboratories overwrote the electronic data and kept only a cursory written record.
It also did not assure reliability of electronic data for monitoring nonviable particles in manufacturing areas. Investigators observed that the company disabled the electronic audit trail function for the nonviable particle monitoring system for several workshops on at least two occasions in August 2017 when a sterile API was manufactured. Also, data files containing particle counts had been modified with no indication of who made the changes or what was modified.
On the solid dose side, inspectors found that the company lacked adequate procedures for its out-of-specification investigations and lacked scientific justification for its invalidated OOS results.
The agency gave Zhuhai United a long list of responses and explanations it wants and strongly suggested the company hire an outside consultant who can help it figure out how to meet cGMP standards.