Chinese API Mfr Sichuan Deebio issued Warning letter over Data Integrity, failure of Quality Unit

USFDA Inspectors Anders W. Evenson and Arsen Karapetyan had inspected the Sichuan Deebio facility (FEI 3011139911) in September 2023. Serious deficiencies were observed during the audit with non-contemporaneous recording of laboratory data in Microbiology QC laboratory, missing test data (electronic data and printouts), failure to extend investigation of product quality complaints to other batches of API, investigate and conclude deviations and establish adequate corrective actions.

Warning letter

FDA 483 to Chinese API Manufacturer Sichuan Deebio cites Data Integrity issues (Qvents News).

Numerous Microbiology Media test plates pertaining to USP API production operations samples, Water samples were found in dust bin with no test data updated in test records. QC team leader mislead the investigators claiming the test records are in QA and later admitting to not recording the data and relying on memory. Customers complained about OOS results for batches when sampled from top, middle and bottom of drug substance batch, microbial failures. But the investigations did not extend to other batches, did not evaluate critical piece of equipment or critical process parameters. No CAPAs are implemented following investigations. Quality unit failed to investigate and resolve deviations in testing methods, additional peaks observed during validation of residual solvents method. For tests performed on Multiparameter analyser equipment with SevenExcellence software, neither electronic data nor print outs were available as data was not backed up and it was claimed that printouts were not available since printer was not connected to the equipment during analysis of the batches. Electronic data review of tests records also showed tests are repeated till desired results are achieved.

In the response to FDA, Sichuan Deebio acknowledged deficiencies, committed improvements in process, retraining personnel, independent third party oversight. However FDA found the response inadequate as it did not have sufficient retrospective review of deficiencies and data records. In the Warning letter FDA stated the Quality system do not ensure accuracy and integrity of data, and asked for comprehensive assessment and remediation plan. FDA also recommend engaging a competent independent cGMP consultant to evaluate the operations and assist the Firm in meeting CGMP requirements.

Sichuan Deebio in responses to FDA has given commitment to suspend production of APIs at the facility for the U.S. market.