FDA Warns Chinese API Manufacturer for a Lack of Written and Quality-Related Procedures

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to China-based active pharmaceutical ingredient (API) manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory for, among other issues, failing to have written procedures on its handling of raw materials.

FDA noted, "When our investigator asked for a list of your critical raw materials and your sampling requirements, you told our investigator that you had no written procedures for testing and sampling incoming materials. Instead, you explained, your warehouse employees accounted for incoming raw material handling, sampling, and testing 'in their heads.'"

The warning letter also revealed that the company "did not have any quality-related procedures in place" before August 2016 "even though you were manufacturing and shipping drugs to the United States."

And though some quality-related procedures were drafted ahead of FDA’s February inspection, the agency said that the company had not yet implemented them.

In addition to recommending the firm find a CGMP consultant to help meet the agency's regulations, FDA also pointed the company to expectations outlined in ICH Q7 in determining whether APIs are manufactured in conformance with CGMP and FDA's guidance on Q7.

Warning Letter for Changzhou Jintan Qianyao Pharmaceutical Raw Materials 5/11/17