# FDA 483 - KOFU FACTORY OF TERUMO CORP. - December 13, 2024

Source: https://www.keypedia.com/records/483/kofu-factory-of-terumo-corp/c1f02c0b-5c3b-4d1d-ae98-1fee8deb8359

> FDA 483 for KOFU FACTORY OF TERUMO CORP. on December 13, 2024. 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: 2024-12-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: KOFU FACTORY OF TERUMO CORP. in Yamanashi, Japan, was inspected and found to have significant deficiencies in its sterile drug product manufacturing. The inspection revealed widespread issues including inadequate aseptic processing controls, environmental monitoring, visual inspection, data integrity, cleaning and sanitization, and overall quality unit oversight. These findings indicate a high severity of non-compliance with GMP regulations, posing a risk to product sterility and quality.

## Related Documents

- [483 - 2023-03-21](https://www.keypedia.com/records/483/kofu-factory-of-terumo-corp/e16f4294-1201-4126-b37c-310c6c5f086b)

## Related Officers

- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Ruo (Rose) H. Xu, Ph.D., Sr. Pharmaceutical Quality Scientist](https://www.keypedia.com/people/ruo-rose-h-xu-phd-sr-pharmaceutical-quality-scientist/40f40b20-ada2-47b0-a329-339ff75f1c09)
- [Zhong Li, Ph.D., Senior Regulatory Specialist](https://www.keypedia.com/people/zhong-li-phd-senior-regulatory-specialist/8239f257-d22a-47ff-af8a-248ff122d717)
- [investigator](https://www.keypedia.com/people/ruo-h-xu/cd7df486-187e-41a2-b424-434fa8b80648)

Company: https://www.keypedia.com/companies/kofu-factory-of-terumo-corp/e0540434-5dcb-4074-851e-f91bd8bfbbf1

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8