# FDA 483 - Engage Uni LLC - November 12, 2021

Source: https://www.keypedia.com/records/483/engage-uni-llc/d50564a6-a374-4848-b47c-8e5d2712084e

> FDA 483 for Engage Uni LLC on November 12, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Engage Uni LLC
- Inspection Date: 2021-11-12
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Engage Uni LLC, a specification developer and complaint file establishment in Orlando, FL, was cited with two observations during an FDA inspection. The firm failed to adequately establish procedures for acceptance activities, resulting in undetected out-of-specification products and undocumented deviations. Additionally, the firm lacked adequate procedures for corrective and preventive actions, specifically regarding the trending and evaluation of quality data.

## Related Officers

- [Recall Coordinator](https://www.keypedia.com/people/emma-schaefer/10299982-dce6-4fea-a3e9-8167030b0331)
- [Brandon P. Thompson](https://www.keypedia.com/people/brandon-p-thompson/a4e7da4f-2e9c-497c-ae4c-9168a9678b91)

Company: https://www.keypedia.com/companies/engage-uni-llc/e39a0cf8-db49-40d6-bad0-fbab7ad101ed

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