# FDA 483 - Chugai Pharma Manufacturing Co. Ltd. - April 02, 2024

Source: https://www.keypedia.com/records/483/chugai-pharma-manufacturing-co-ltd/4d34740b-5987-4cee-8d49-ef929ff773fd

> FDA 483 for Chugai Pharma Manufacturing Co. Ltd. on April 02, 2024. 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: 2024-04-02
- 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, a sterile drug manufacturer, revealed a significant deficiency in their aseptic processing. The firm's procedures for preventing microbial contamination of sterile drug products lacked adequate validation of the aseptic process, specifically concerning a smoke study that did not accurately simulate actual processing conditions. This issue impacts numerous vials of finished drug product released for commercial distribution in the U.S.

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## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

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