Chinese Firm Cited for Recordkeeping Violations, Inadequate Testing

The FDA hit Tianjin-Jingye Fine Chemicals with a Form 483 for 14 violations, ranging from inappropriate re-injection and outdated stability research to lack of hand-washing facilities.

A January 2016 inspection of the Tianjin, China-based firm found the quality control staff conducted re-injection of high-performance liquid chromatography samples “without justification, written documentation or approval.”

The company also conducted residual solvent testing on certain products without written justification.