# FDA 483 - Terumo Medical Corporation - October 28, 2022

Source: https://www.keypedia.com/records/483/terumo-medical-corporation/f462bd5d-fd61-4d02-ae1b-c50b0354f2a1

> FDA 483 for Terumo Medical Corporation on October 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Terumo Medical Corporation
- Inspection Date: 2022-10-28
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: Terumo Medical Corporation, a medical device manufacturer in Elkton, MD, received one observation during an FDA inspection. The observation highlighted that procedures for the review and disposition of nonconforming product were not adequately established. Specifically, the firm failed to document nonconforming material disposition in 13 out of 25 sampled records, indicating a lapse in quality system compliance.

## Related Documents

- [483 - 2019-06-20](https://www.keypedia.com/records/483/terumo-medical-corporation/79a2c9f1-4910-49c9-8a36-209ea035e676)

## Related Officers

- [Lindsey L Kirsh](https://www.keypedia.com/people/lindsey-l-kirsh/78c606cb-8c62-4b99-9e71-56ab53ed2a3c)
- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/terumo-medical-corporation/436e47e6-b836-4f48-9dbf-0a2f76c31902

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64