# FDA 483 - Dolor Technologies LLC - September 19, 2019

Source: https://www.keypedia.com/records/483/dolor-technologies-llc/eb039565-42d6-4d05-9e7e-ee592a650d30

> FDA 483 for Dolor Technologies LLC on September 19, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Dolor Technologies LLC
- Inspection Date: 2019-09-19
- Product Type: device
- Office Name: Denver District Office
- Summary: Poler Technologies LLC, a medical device specification developer in Syracuse, UT, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to establish written procedures for Medical Device Reporting (MDR) and for handling customer complaints. Additionally, two received complaints were not evaluated for MDR reporting, documented, or investigated, indicating a fundamental failure to meet regulatory requirements.

## Related Officers

- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/dolor-technologies-llc/dab077b4-fd5a-455c-a1b3-1b1ed500d75f

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face