# FDA 483 - Chugai Pharma Manufacturing Co. Ltd. - September 01, 2017

Source: https://www.globalkeysolutions.net/records/483/chugai-pharma-manufacturing-co-ltd/ee577c44-8836-4d26-b356-0b0995835728

> FDA 483 for Chugai Pharma Manufacturing Co. Ltd. on September 01, 2017. 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: 2017-09-01
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Chugai Pharma Manufacturing Co., Ltd. in Utsunomiya City, Japan, revealed several significant deficiencies in their manufacturing and quality control processes. Observations included inadequate smoke studies for filling lines, insufficient quality assurance oversight, and failures in deviation management. The firm also had issues with the validation of its electronic Manufacturing Execution System and non-compliance with pest control procedures.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/aimee-cunningham/c49df6e2-a332-4f77-890f-213e3b3ddfb7)
- [Marion Michaelis](https://www.globalkeysolutions.net/people/marion-michaelis/4fa99c28-0925-4618-b5c7-fc610573284b)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321