# FDA 483 - TERUMO YAMAGUCHI CORPORATION - March 30, 2023

Source: https://www.keypedia.com/records/483/terumo-yamaguchi-corporation/d47937e0-182b-47e6-a192-af22f0393f7f

> FDA 483 for TERUMO YAMAGUCHI CORPORATION on March 30, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TERUMO YAMAGUCHI CORPORATION
- Inspection Date: 2023-03-30
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: TERUMO YAMAGUCHI CORPORATION, a sterile drug manufacturer in Yamaguchi, Japan, was cited with two observations during an FDA inspection. The inspection revealed deficiencies related to the sampling and testing of components for sterile drug products and issues with data integrity, specifically concerning the security and completeness of backup data for analytical equipment.

## Related Documents

- [483 - 2020-02-21](https://www.keypedia.com/records/483/terumo-yamaguchi-corporation/da05dabd-7392-4090-ad82-f590ea4131b8)
- [483 - 2023-03-30](https://www.keypedia.com/records/483/terumo-yamaguchi-corporation/f49bcd42-4492-4580-bf15-5f9bf269ffbf)

## Related Officers

- [Investigator](https://www.keypedia.com/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)
- [Melanie W. Pishnery](https://www.keypedia.com/people/melanie-w-pishnery/ff4846b0-ffe1-4df0-9116-4bb238866b3a)

Company: https://www.keypedia.com/companies/terumo-yamaguchi-corporation/475daebd-e907-4c43-855d-63dd50cf5a9f

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