# FDA 483 - Terumo Medical Corporation - June 20, 2019

Source: https://www.keypedia.com/records/483/terumo-medical-corporation/79a2c9f1-4910-49c9-8a36-209ea035e676

> FDA 483 for Terumo Medical Corporation on June 20, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Terumo Medical Corporation
- Inspection Date: 2019-06-20
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Terumo Medical Corporation in Elkton, MD, a device manufacturer, revealed significant deficiencies in quality system controls. Observations included inadequate control of nonconforming products, unestablished quality system procedures for risk evaluation, and failures in equipment calibration and maintenance protocols. These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2022-10-28](https://www.keypedia.com/records/483/terumo-medical-corporation/f462bd5d-fd61-4d02-ae1b-c50b0354f2a1)

## Related Officers

- [investigator](https://www.keypedia.com/people/daniel-t-lee/8147e5b2-2065-42e3-b86c-36c0231f74cc)
- [Jacob M Dyer](https://www.keypedia.com/people/jacob-m-dyer/e3ca27e3-e0b1-4db8-9cbe-cfaff90b83cf)

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

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8