FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Chinese Firm Cited for Recordkeeping Violations, Inadequate Testing

March 8, 2017
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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FDA hit Tianjin-Jingye Fine Chemicals with a Form 483 for 14 violations, ranging from inappropriate re-injection and outdated stability research to lack of hand-washing facilities.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.

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