# FDA 483 - Micron Medical Corporation - January 26, 2021

Source: https://www.globalkeysolutions.net/records/483/micron-medical-corporation/71a30c5b-d66a-4b2b-a3f3-0d05d90cb8d1

> FDA 483 for Micron Medical Corporation on January 26, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Micron Medical Corporation
- Inspection Date: 2021-01-26
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Micron Medical Corporation, a sponsor in Boca Raton, FL, was inspected regarding its conduct and oversight of an investigational device study. The inspection revealed significant deficiencies in the evaluation and reporting of unanticipated adverse device effects, inadequate monitoring of clinical sites, and incomplete device accountability records. Additionally, the firm failed to submit required annual progress reports to the FDA and IRBs.

## Related Officers

- [Richard A. Lyght](https://www.globalkeysolutions.net/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)
- [issuing_officer](https://www.globalkeysolutions.net/people/sheri-l-stephenson/dd4f3755-bb3b-4a14-a08f-8d59fbb0b6fa)

Company: https://www.globalkeysolutions.net/companies/micron-medical-corporation/ef576cd0-4205-40a9-bd28-1f61d81b8d19

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6