# FDA 483 - Kyowa Kirin Pharmaceutical Research, Inc. - March 02, 2020

Source: https://www.globalkeysolutions.net/records/483/kyowa-kirin-pharmaceutical-research-inc/028268d7-a893-4fb4-ac16-704d14aa63c5

> FDA 483 for Kyowa Kirin Pharmaceutical Research, Inc. on March 02, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kyowa Kirin Pharmaceutical Research, Inc.
- Inspection Date: 2020-03-02
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Kyowa Kirin Pharmaceutical Research, Inc.'s biopharmaceutics analytical facility in La Jolla, California, from March 2-6, 2020, revealed a significant data integrity issue. The firm failed to report all precision and accuracy data from method validations associated with multiple studies. This indicates a concern regarding the completeness and reliability of their analytical data.

## Related Officers

- [Melkamu Getie-Kebtie PhD, RPh, Pharmacologist](https://www.globalkeysolutions.net/people/melkamu-getie-kebtie-phd-rph-pharmacologist/614a1bb2-1046-48db-b151-3207116a1fe0)
- [Amanda E. Lewin, PhD, Pharmacologist](https://www.globalkeysolutions.net/people/amanda-e-lewin-phd-pharmacologist/06bee243-0210-4566-b57f-ce5a3a1c5e57)
- [investigator](https://www.globalkeysolutions.net/people/sherri-n-rohlf/41090ab1-83d1-4e95-92ea-0cfca5cecdb6)

Company: https://www.globalkeysolutions.net/companies/kyowa-kirin-pharmaceutical-research-inc/fd31ad2f-eaa2-48e1-9d1e-1f7b43e55a36

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6