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

Source: https://www.keypedia.com/records/483/oishi-koseido-co-ltd/c4184f8f-2cc1-4fca-9c24-7ca01e87c9d1

> FDA 483 for Oishi Koseido Co., Ltd. on September 01, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oishi Koseido Co., Ltd.
- Inspection Date: 2023-09-01
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Documents

- [483 - 2023-09-01](https://www.keypedia.com/records/483/oishi-koseido-co-ltd/340e20ce-d157-4932-843e-26b98d0ad2dd)

## Related Officers

- [Teresa I. Navas](https://www.keypedia.com/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.keypedia.com/companies/oishi-koseido-co-ltd/07ae7f38-2728-4248-8ef1-ff0abd9a79e7

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c