The FDA warned API manufacturer Yuki Gosei Kogyo about major data integrity violations observed during a Nov. 13-17 inspection of its facility in Fukushima, Japan.
The agency found the company failed to ensure complete product testing data was included in the official batch record and reviewed by the quality unit.
The company reported passing results for related substances testing for at least one lot in July 2015, but investigators found unreported analyses including out-of-specification results for the same lot. It did not include the data for review by its quality unit ahead of the lot’s release, the agency said.
In response to the findings, company acknowledged a retrospective review after the inspection turned up further instances of unreported electronic data in original batch records.
“Your review only assessed laboratory data and did not assess all parts of your facility’s operation where CGMP information is generated and maintained,” the agency said.
The FDA asked the company to conduct a full investigation into data inaccuracies, including an analysis of protocol and methodology, interviews with current and former employees (ideally by a third party), an assessment of how deep the data integrity deficiencies at the facility go, and a retrospective review of testing and manufacturing problems.
The agency also called for a current risk assessment of how the observed failures could affect the quality of the drugs, including potential risks to patients.