# FDA 483 - Chugai Pharma Manufacturing Co. Ltd. (CPMC) - March 29, 2024

Source: https://www.keypedia.com/records/483/chugai-pharma-manufacturing-co-ltd-cpmc/ce2105ec-0fa6-423d-a50d-5443677ed1b2

> FDA 483 for Chugai Pharma Manufacturing Co. Ltd. (CPMC) on March 29, 2024. 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: 2024-03-29
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Chugai Pharma Manufacturing Co., Ltd. (CPMC) in Tokyo, Japan, a drug substance manufacturer, was cited with five observations during an FDA inspection. The findings highlight significant concerns including risks of viral cross-contamination in drug substance manufacturing, inadequate protection of laboratory electronic data, and deficiencies in written production and process control procedures. Additionally, the inspection revealed issues with adherence to standard operating procedures, pest control, employee training, and overall facility maintenance, indicating a need for comprehensive corrective actions to ensure product quality and compliance.

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## Related Officers

- [Jacek Cieslak](https://www.keypedia.com/people/jacek-cieslak/81b12add-49f1-4dfd-bcb1-60bc5b212b68)
- [other](https://www.keypedia.com/people/hamet-m-toure/9f3726f3-b118-4247-9793-738557aa1ee8)

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