# FDA 483 - KOFU FACTORY OF TERUMO CORP. - March 21, 2023

Source: https://www.keypedia.com/records/483/kofu-factory-of-terumo-corp/e16f4294-1201-4126-b37c-310c6c5f086b

> FDA 483 for KOFU FACTORY OF TERUMO CORP. on March 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KOFU FACTORY OF TERUMO CORP.
- Inspection Date: 2023-03-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: KOFU FACTORY OF TERUMO CORP. in Nakakoma-Gun, Japan, a sterile drug manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies in aseptic processing areas, environmental controls, and quality control procedures. These issues indicate a lack of adequate measures to prevent contamination and ensure drug product sterility and quality.

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## 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/kofu-factory-of-terumo-corp/e0540434-5dcb-4074-851e-f91bd8bfbbf1

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