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FDA’s CDER Warns China- and Mexico-based Drugmakers

Posted 30 April 2018 | By Zachary Brennan 

FDA’s CDER Warns China- and Mexico-based Drugmakers

The US Food and Drug Administration (FDA) last week released two warning letters sent by its Center for Drug Evaluation and Research to Mexico City-based finished pharmaceutical manufacturer Degasa and Lijiang, China-based active pharmaceutical ingredient (API) manufacturer Lijiang Yinghua Biochemical and Pharmaceutical Co.

For Degasa, FDA said that following an inspection last September, the firm had numerous misbranding issues, failed to implement adequate microbial testing and “lacked basic information” on its water system’s performance.

“Significant findings in this letter indicate that your quality unit is not able to fully exercise its authority and/or responsibilities,” the warning letter to Degasa sent 18 April said. 

In response to the warning, FDA is calling on the firm to test, within 30 days, all batches to determine their microbial quality, in addition to “an independent, comprehensive assessment of the manufacturing operations used to manufacture each of your topical drug products, with special emphasis on material inputs, enhanced bioburden controls, and contamination prevention.” 

And for Lijiang Yinghua Biochemical and Pharmaceutical Co., FDA warned the company for data integrity questions and because the company’s quality unit approved the certificate of analysis (COA) to release an API batch to a customer before testing was complete and available for review.

FDA also found repeat CGMP deviations from an inspection conducted in 2015, and the company was placed on import alert on 8 February 2018.

“Our current inspection identified multiple failures to implement your specific corrective actions. These repeated failures demonstrate that your facility’s oversight and control over the manufacture of drug products is inadequate,” FDA said.

Degasa S.A. De C.V. 4/18/18

Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. 4/19/18

Categories: Regulatory News

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