# FDA 483 - Chugai Pharma Manufacturing Co. Ltd. (CPMC) - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/chugai-pharma-manufacturing-co-ltd-cpmc/8800ab63-5e51-46a0-a37a-cd86c0475cf4

> FDA 483 for Chugai Pharma Manufacturing Co. Ltd. (CPMC) on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chugai Pharma Manufacturing Co. Ltd. (CPMC)
- Product Type: drugs
- Office Name: Division of Inspectional Assessment
- Summary: Chugai Pharma Manufacturing Co., Ltd. in Kita-ku, Tokyo, Japan, a drug substance manufacturing facility, received an FDA Form 483 for multiple significant deficiencies. Observations included untimely resolution of deviations, approval of raw materials before complete testing, and inadequate Standard Operating Procedures. Further issues involved insufficient equipment cleaning validation, deficient controls for defective materials, inadequate environmental cleaning, poor preventative maintenance, and incomplete master batch records.

## Related Documents

- [483 - 2020-02-21](https://www.globalkeysolutions.net/records/483/chugai-pharma-manufacturing-co-ltd-cpmc/e217457b-4b3e-48d9-a6f0-eebe15123e22)
- [483 - 2021-08-23](https://www.globalkeysolutions.net/records/483/chugai-pharma-manufacturing-co-ltd-cpmc/7512576a-58d4-449a-bfc4-743a9c5fe960)
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- [483 - 2024-03-29](https://www.globalkeysolutions.net/records/483/chugai-pharma-manufacturing-co-ltd-cpmc/ce2105ec-0fa6-423d-a50d-5443677ed1b2)

## Related Officers

- [Nina Brahme, Ph.D., M.P.H., Staff Fellow](https://www.globalkeysolutions.net/people/nina-brahme-phd-mph-staff-fellow/65767961-e4ed-4b35-9f82-7bd7f767de99)
- [Leslie A Rivera-Rosado, Ph.D., Regulatory Officer](https://www.globalkeysolutions.net/people/leslie-a-rivera-rosado-phd-regulatory-officer/f0a00671-d5ef-46bc-96db-9a6fd1227608)
- [Maxwell Van Tassell, Ph.D., Microbiologist](https://www.globalkeysolutions.net/people/maxwell-van-tassell-phd-microbiologist/582e4c55-65af-48d5-bd67-7f32adbcb268)
- [Bo Chi, Ph.D., Microbiologist](https://www.globalkeysolutions.net/people/bo-chi-phd-microbiologist/69ddbe08-9e55-44fa-8cc3-96b19c9b21fd)

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

Office: https://www.globalkeysolutions.net/offices/division-of-inspectional-assessment/9bc7aff2-93a7-404a-8015-0f93c3701c13