Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

U.S. Food and Drug Administration (FDA) Inspection Cites Chinese Firm for API Issues – Includes Import Alert and Warning Letter 

By Leave a Comment

The U.S. Food and Drug Administration (FDA) inspected manufacturing facilities,   Changzhou Jintan Qianyao Pharmaceutical Raw Materials, from February 13-17, 2017.  As a result of significant deviations from current good manufacturing practice (CGMP), the FDA placed the firm on Import Alert 66-40 on May 4, 2017.  Subsequent to … [Read more...]