# FDA 483 - Ophtec USA, Inc. - June 24, 2022

Source: https://www.keypedia.com/records/483/ophtec-usa-inc/be0a44cd-f063-4bed-b27a-72a6ce4f0ca0

> FDA 483 for Ophtec USA, Inc. on June 24, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ophtec USA, Inc.
- Inspection Date: 2022-06-24
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Ophtec USA, Inc. in Sunrise, FL, a commercial sponsor-monitor, revealed one observation. The firm failed to consistently submit current lists of investigator names and addresses to the FDA at required intervals after investigation approval. This indicates a lapse in regulatory reporting for clinical investigations.

## Related Officers

- [Richard A. Lyght](https://www.keypedia.com/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

Company: https://www.keypedia.com/companies/ophtec-usa-inc/093d4747-f79f-4568-be35-653fe1eb6e75

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