# FDA 483 - Chugai Pharma Manufacturing Co. Ltd. (CPMC) - August 23, 2021

Source: https://www.keypedia.com/records/483/chugai-pharma-manufacturing-co-ltd-cpmc/7512576a-58d4-449a-bfc4-743a9c5fe960

> FDA 483 for Chugai Pharma Manufacturing Co. Ltd. (CPMC) on August 23, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chugai Pharma Manufacturing Co. Ltd. (CPMC)
- Inspection Date: 2021-08-23
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Chugai Pharma Manufacturing Co., Ltd., Ukima Plant, a drug substance manufacturer in Kita-Ku, Tokyo, Japan, was cited with six observations during an FDA inspection. The observations primarily concern inadequate cleaning procedures and validation, insufficient data integrity controls for electronic systems, and deficiencies in following or establishing standard operating procedures. These issues indicate a lack of robust quality control and assurance in their manufacturing processes.

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## Related Officers

- [Jacek Cieslak, Ph.D., Chemist](https://www.keypedia.com/people/jacek-cieslak-phd-chemist/52653877-415a-4dfd-b5e1-820bab165d96)
- [Zhong Li, Ph.D., Sr. Pharmaceutical Quality Assessor](https://www.keypedia.com/people/zhong-li-phd-sr-pharmaceutical-quality-assessor/cdc177bb-92f6-4d53-ba84-6e878c68917a)

Company: https://www.keypedia.com/companies/chugai-pharma-manufacturing-co-ltd-cpmc/946be668-0540-474b-822b-8a4a81e5284f

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd