# FDA 483 - Chugai Pharma Manufacturing Co. Ltd. - February 21, 2020

Source: https://www.globalkeysolutions.net/records/483/chugai-pharma-manufacturing-co-ltd/6d845505-2d19-4be5-b738-c8af14de1380

> FDA 483 for Chugai Pharma Manufacturing Co. Ltd. on February 21, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chugai Pharma Manufacturing Co. Ltd.
- Inspection Date: 2020-02-21
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Chugai Pharma Manufacturing Co. Ltd in Utsunomiya, Japan, a drug product manufacturer, was cited for significant deficiencies in its manufacturing processes. The inspection revealed failures to establish and follow appropriate procedures to prevent microbiological contamination of sterile drug products, specifically concerning aseptic and sterilization process validation. Additionally, the firm's test methods were found to be inadequately validated or verified.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/zhihao-peter-qiu/2fb1af05-1c5a-4b75-87e0-ba0edaaf4adb)

Company: https://www.globalkeysolutions.net/companies/chugai-pharma-manufacturing-co-ltd/09ba6515-9227-444c-a24c-a6cb8da9e235

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