FDA 483 - Olaregen Therapeutix Inc. - April 03, 2020

Olaregen Therapeutix Inc., a medical device manufacturer in New Hyde Park, NY, was issued a Form FDA 483 following an inspection. The inspection revealed a significant compliance issue related to the firm's failure to maintain written Medical Device Reporting (MDR) procedures. Specifically, the firm lacked electronic MDR procedures for submitting reports on serious injuries and death incidents.