The FDA found serious GMP violations during an inspection of a drug manufacturing facility in Guangzhou, China.
The agency issued a seven-item Form 483 to Guangzhou Tinci Materials Technology documenting a litany of failures, ranging from inadequate equipment for controlling the manufacturing environment, to failure to investigate out-of-specification results.
The investigators found that the clean workshop lacked proper controls for air pressure, microorganisms, dust, temperature and humidity for manufacturing a liquid bulk product shipped to the U.S.
In addition, the quality unit lacked the authority to approve or reject drug products, or to review production records to assure that no errors occurred. Batch records indicated five significant deviations but the quality unit failed to investigate and the product was shipped.