Data Removal, Investigation Delays Draw Warning for Hebei Yuxing Bio-Engineering

Hebei Yuxing Bio-Engineering, a Chinese producer of active pharmaceutical ingredients, received a warning letter from the FDA citing significant cGMP and data integrity issues discovered at its manufacturing plant.

The investigation, conducted in August 2015, revealed “experimental” analyses on product batches to assess whether API specifications were met, but failed to document these “experimental” tests in official laboratory records or to justify their exclusion.

Additionally, the investigation found that laboratory analysts deleted raw chromatographic data on multiple occasions and failed to follow and document laboratory controls at the time of performance. The letter also cited the failure of the quality unit to ensure that all critical deviations are investigated and resolved and a quality system that does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured.