483
Dolor Technologies LLCDolor Technologies LLC – FDA 483, Sep 19, 2019
Record Details
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.
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ID · eb039565-42d6-4d05-9e7e-ee592a650d30
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