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FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.
FDA issued a warning letter to Tianjin Zhongan Pharmaceutical on June 10, 2014 for cGMP violations for APIs that FDA identified in an inspection of the Tianjin, China plant from Sept. 23 to Sept. 27, 2013. Deviations cited included failure to adequately complete and follow written procedures for cleaning equipment and to maintain adequate records of major equipment usage, failure to conduct adequate change control, and failure to adequately review and investigate product deviations.
An inspection found that employees did not adequately clean equipment after use. FDA also noted that the firm "did not maintain equipment logs or other documents that adequately record manufacturing operations performed on individual pieces of equipment."
Although employees had been trained in change control procedures, FDA found that they failed to comply with procedures and that the company's response did not give enough detail on how compliance would be ensured.
Inspectors found that the company failed to adequately investigate deviations and did not adequately control certificates of analysis. FDA also cited concerns about inadequate qualification of critical production equipment.
FDA concluded, "Your inability to detect and prevent the above deficient practices, as well as other deficiencies found during the inspection, indicate that your current quality system is ineffective at achieving overall compliance with cGMP." The agency recommended that the firm engage a third-party consultant with appropriate cGMP expertise.