FDA 483 - Dolor Technologies LLC - September 19, 2019

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.