# FDA 483 - Chugai Pharma Manufacturing Co. Ltd. - September 26, 2019

Source: https://www.keypedia.com/records/483/chugai-pharma-manufacturing-co-ltd/fb1f6419-98cd-4518-a9f4-7ccbaccef3d3

> FDA 483 for Chugai Pharma Manufacturing Co. Ltd. on September 26, 2019. 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: 2019-09-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Chugai Pharma Manufacturing Co. Ltd. in Utsunomiya, Japan, revealed significant deficiencies in laboratory controls, production systems, and quality control. Repeat observations from previous inspections highlight ongoing issues with data integrity, electronic record management, and the adequacy of visual inspection processes for finished drug products. The firm also failed to adequately investigate product complaints and deviations, indicating a systemic breakdown in quality oversight.

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## Related Officers

- [Cheryl A. Clausen](https://www.keypedia.com/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1