# CMIC Pharma Science Co., Ltd. – FDA 483, Sep 3, 2026

Source: https://www.keypedia.com/records/483/cmic-pharma-science-co-ltd/cbe848fb-22e6-45e5-b956-8ca2d29c5521

> FDA 483 for CMIC Pharma Science Co., Ltd. on September 03, 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: 2026-09-03
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of CMIC Pharma Science Co., Ltd. in Ishikari, Japan, a control testing laboratory, revealed a significant issue regarding the lack of scientific justification for temperature probe placement. The firm failed to properly document worst-case locations within temperature-controlled environments used for testing, storage, and handling of Active Pharmaceutical Ingredients. This indicates a deficiency in their written program for routine calibration and performance assurance of equipment.

## 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/8b766eee-fafd-486b-ab76-e4df56227a93

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8