China Facility Receives FDA Warning Letter

September 23, 2016

Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.

FDA sent a warning letter to Hebei Yuxing Bio-Engineering Co. Ltd. on Sept. 6, 2016 citing the company for violations of current good manufacturing practice (CGMP), specifically in regards to data integrity. The letter follows an FDA inspection conducted August 17–21, 2015.

During the 2015 inspection, investigators observed data integrity issues including laboratory control records that did not include complete laboratory testing data. Experimental analyses conducted prior to official analyses were not documented in official records, and inspectors also found audit trails that showed analysts deleted raw chromatographic data.

“Your firm indicated that analysts may have been testing the system and may have deleted associated files. You also indicated that the deleted files may represent aborted analyses. However, we documented that some audit trail entries of deleted raw data files contained batch numbers for actual batch samples being tested. There is no assurance that laboratory records and raw data are accurate and valid,” FDA states in the letter. 

The letter also states that the company failed to ensure that all critical deviations were investigated and resolved. The company documented the finding of microbial contamination from January 1 through August 20, 2015, but FDA states microbial contamination had been “a persistent and unresolved problem” since 2013. FDA states that while the company had identified potential causes of the contamination, it had not identified the specific root cause or taken appropriate corrective actions and preventative actions (CAPA).

FDA recommends the company perform a comprehensive data recording investigation and a risk assessment of potential effects of observed failures on product quality. The agency also suggested the company come up with a management strategy for CAPA.

Source: FDA