# FDA 483 - DS REP B.V. - June 16, 2022

Source: https://www.keypedia.com/records/483/ds-rep-bv/512abc54-152e-4fd1-a5af-e6494be796cc

> FDA 483 for DS REP B.V. on June 16, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: DS REP B.V.
- Inspection Date: 2022-06-16
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Dentsply Sirona Prosthetics in Las Piedras, PR, from June 13-16, 2022, revealed two significant issues. The firm failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements, including a lack of defined supplier requirements and unimplemented quality agreements. Additionally, the inspection found that personnel training, specifically for an employee conducting manufacturing operations, was not documented.

## Related Officers

- [Nydia E. Colon](https://www.keypedia.com/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

Company: https://www.keypedia.com/companies/ds-rep-bv/72eac62e-7ba1-46ff-8139-383dcd7cd6e4

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