Data Inconsistency, Investigation Lapses 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.

Until all deviations are completely corrected and compliance with cGMP is confirmed, the FDA said it may withhold approval of any new applications or supplements listing the firm as a drug manufacturer. The agency also stated that if actions to resolve the issues lead to a stoppage in the supply of drugs the plant manufactures, the company should contact the agency.

It’s in the news all the time these days: drug and devicemakers getting warning letters for failing to protect the integrity of their data. The FDA is on a quest to weed out false information and errors in the records.

A single integrity issue calls into question all the data produced by a company, FDA officials say. Just take 10 minutes with FDAnews Data Integrity Compliance and it can teach your employees all they need to know about the concept of data integrity.