FDA 483 - Aerolase Corp. - August 08, 2019

Aerolase Corporation, a manufacturer and importer of medical lasers in Tarrytown, NY, was cited for four observations during an FDA inspection. The inspection revealed deficiencies related to laser product safety features, inadequate operating instructions and hazard warnings, undeveloped Medical Device Reporting (MDR) procedures, and poorly maintained device history records. These issues indicate a need for improved compliance with regulatory requirements for medical device manufacturing.