# CMIC Pharma Science Co., Ltd. – FDA 483, Aug 31, 2026

Source: https://www.keypedia.com/records/483/cmic-pharma-science-co-ltd/2707b63f-4a32-4608-a775-993c7d33b707

> FDA 483 for CMIC Pharma Science Co., Ltd. on August 31, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CMIC Pharma Science Co., Ltd.
- Inspection Date: 2026-08-31
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: CMIC Pharma Science Co., Ltd., a contract testing laboratory in Ishikari, Japan, was cited for significant deficiencies in data integrity, equipment qualification, and analytical method validation. The inspection revealed issues including the use of unvalidated Excel spreadsheets for critical calculations, incomplete performance qualification for HPLC systems, and a lack of method transfer or site-specific validation for analytical test procedures. These findings indicate a serious lack of control over data and testing processes for drug products.

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.keypedia.com/companies/cmic-pharma-science-co-ltd/899a29c9-6887-4893-9ebe-16aef51402ff

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3