Regulatory Focus™ > News Articles > 2019 > 11 > FDA Warns Chinese Drugmaker Over GMP, Data Integrity Violations

FDA Warns Chinese Drugmaker Over GMP, Data Integrity Violations

Posted 06 November 2019 | By Michael Mezher 

FDA Warns Chinese Drugmaker Over GMP, Data Integrity Violations

The US Food and Drug Administration (FDA) last month warned Chinese drugmaker Bingbing Pharmaceutical for good manufacturing practice (GMP) and data integrity issues, some of which stem from the company losing records after moving to a new facility.
 
The warning letter, which follows a four-day inspection of the company’s Hubei facility last May, details four violations related to record keeping, ingredient testing, quality control and complaint handling.
 
According to FDA, Bingbing failed to retain records, reports and samples for its over-the-counter (OTC) drugs made at its former facility in Wuhan after transferring production of the products to the Hubei facility in May 2018.
 
“During the inspection at the Hubei facility, you stated that you lost cGMP manufacturing documentation and drug product samples during the transfer,” FDA writes.
 
In response, FDA says the company needs to conduct an independent assessment of its documentation systems and develop a corrective and preventative action (CAPA) plan to address its documentation issues, as well as a risk assessment on the impact the missing records have on any of its marketed products.
 
FDA also says the company released OTC drugs “without testing the identity and strength of each active ingredient.”
 
In response, Bingbing committed to discontinuing distribution of those products until it establishes validated analytical methods for testing the ingredients.
 
The warning letter also cites Bingbing for failing to maintain an adequate written record of its complaint investigations. Specifically, FDA says the company “found no deficiencies” in reserve samples evaluated as part of two complaint investigations, but FDA notes that “all reserve samples were lost” after the company switched facilities “and therefore reserve samples were not available for evaluation.”
 
In addition to those violations, FDA cites the company’s quality unit for seven different issues with qualifying a contract laboratory, ensuring written procedures are followed and failing to investigate out-of-specification test results.
 
FDA

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe