FDANews
The QMN Weekly Bulletin

FDA Warns Chinese API Manufacturer Over Quality Management, Record-Keeping

May 26, 2017

The FDA warned Chinese API manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Materials for inadequate quality management and record-keeping.

Following a February inspection of the firm’s Changzhou City facility, the FDA issued a warning letter, citing the company’s lack of quality management. Prior to last August, inspectors wrote, the firm had no quality-related procedures at all, and while some procedures had been drafted by February 2017, they were not implemented as of the inspection.

The facility also had no written procedures for testing and sampling incoming materials, with company representatives telling FDA investigators they had simply committed the procedures to memory. The facility failed to produce laboratory control records with complete data from all laboratory tests. The company batch records were similarly lacking, with one operator simply reusing data from previous batches.

The agency urged the company to hire a CGMP consultant to help address the issues.

The Investigations Operations Manual is the primary policy guide for FDA investigations and directs the conduct of all fundamental field investigational activities. Adherence to the manual is required. Make sure you’ve got the latest version before the FDA knocks on your door.

View today's stories