FDA Cites Chinese API Firm for Falsified Documents

January 14, 2020

The FDA slapped a Shanghai API manufacturer with a Form 483 for falsifying GMP documents and other serious failures.

Shanghai Co-Fun Biotech falsified all of its GMP documents “by simply writing the worksheets, validation protocols, validation reports, change controls, deviations, calibration records, testing records” and other items, the agency found. All of the documents and related SOPs were signed and backdated to look as if they occurred in 2018 and 2019.

The quality unit also faked stability sample data sheets, listing batches that were never manufactured and created the sheets just days before the agency’s inspection.

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