FDA 483 - Oishi Koseido Co., Ltd. - September 01, 2023

The FDA inspection of a pharmaceutical manufacturing facility revealed several significant violations.

**Facility and Operations:** The firm commissioned a new building for commercial US market product manufacturing without utilizing a change management system or issuing a change control. The performance qualification of manufacturing areas lacked a protocol and a formal report.

**Quality Control and Data Integrity:** * **Data Accuracy:** During operational qualification of GPD700 and G710, samples for calibration curve evaluation were prepared. * **Data Deletion/Manipulation:** QC analysts could delete and rename raw data files from Trapezium X. The QC Manager and IT personnel failed to demonstrate that deletions were captured by the software's event/audit trail log. Files were found in the computer's trash bin without explanation. * **Audit Trail Deficiencies:** An injection sequence of standards was deleted in Lab Solutions without documentation or remarks. The QC Supervisor stated no justification was required for pre-acquisition deletions, but this is not in an SOP. SOP DM4710I for audit trail review is not comprehensive, lacking instructions for Empower, Lab Solutions, and Trapezium X.

**Quality System and Manufacturing Issues:** * **Stability Testing:** No written testing program or protocols exist for assessing drug product stability. Document DM04218-01, provided as a stability protocol, lacks details on test methods, sample size, and storage conditions. * **Equipment Maintenance:** Major equipment maintenance records are