# FDA 483 - Encore, Inc. - February 20, 2020

Source: https://www.globalkeysolutions.net/records/483/encore-inc/ade7711c-1c79-4a81-a178-1e32253de6e5

> FDA 483 for Encore, Inc. on February 20, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Encore, Inc.
- Inspection Date: 2020-02-20
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Encore, Inc., a medical device specification developer in Sarasota, FL, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection cited inadequate procedures for controlling nonconforming product, managing purchased services, handling complaints, and documenting design changes. These issues indicate a lack of robust controls over critical aspects of medical device development and manufacturing.

## Related Officers

- [Principal ](https://www.globalkeysolutions.net/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.globalkeysolutions.net/companies/encore-inc/d8bce4a4-9398-45e6-93e4-6652bc0704e0

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