FDA 483 - Dentaline LLC - July 29, 2021

Dentaline LLC, a medical device importer in Brooklyn, NY, received two observations during an FDA inspection. The firm was cited for not having written procedures for Medical Device Reporting (MDR), including electronic MDR and an Electronic Submissions Gateway account. Additionally, the inspection found a lack of established procedures for corrective and preventive actions (CAPA) related to medical device investigations.