# FDA 483 - TERUMO YAMAGUCHI CORPORATION - February 21, 2020

Source: https://www.keypedia.com/records/483/terumo-yamaguchi-corporation/da05dabd-7392-4090-ad82-f590ea4131b8

> FDA 483 for TERUMO YAMAGUCHI CORPORATION on February 21, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TERUMO YAMAGUCHI CORPORATION
- Inspection Date: 2020-02-21
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Terumo Yamaguchi D&D Corporation in Yamaguchi, Japan, a drug product manufacturer, revealed significant deficiencies across multiple areas. These include inadequate aseptic processing controls, unqualified personnel for critical inspections, insufficient validation of sterile hold times, and a deficient environmental monitoring program. The findings indicate a need for comprehensive improvements in quality systems, equipment maintenance, and personnel training to ensure the sterility and quality of drug products.

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## Related Officers

- [Virginia A. Carroll](https://www.keypedia.com/people/virginia-a-carroll/180e8c1a-1712-4701-9399-9758573ef8d8)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd