Validation Times - Chinese API maker looks to state for calibration service.(Brief Article)
FDA’s May 28-June 1, 2001, inspection of API make Northeast General Pharmaceutical Factory of Shenyang, China, netted the maker of bulk sucralfate U.S.P. four citations on the Oct. 2 warning letter for stability records and calibration lapses. The Division of Manufacturing & Product Quality at the Center for Drugs informed the firm that CDER would recommend withholding approval of NDAs listing Northeast’s product as a component.
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The agency cited the firm for lack of documentation that would allow tracing of three samples of sucralfate used in stability testing back to the …
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