FDA 483 - Optim LLC - May 29, 2025

Optim LLC, a manufacturer of nasopharyngoscopes in Sturbridge, MA, received two observations during an FDA inspection. The firm was cited for deficiencies in its design history files, specifically regarding the verification of illumination output for its ENTity XL and ENTity SDXL devices. Additionally, the device history records were found to be incomplete, lacking unique device identifiers and finished device labeling.