FDA 483 - Inova Lasers LLC - February 07, 2020

Inova Lasers LLC, a medical device manufacturer in New York, NY, was inspected by the FDA and received a Form 483 with 11 observations. The inspection revealed significant deficiencies across multiple quality system areas, including product certification, design controls, labeling, purchasing controls, product reporting, complaint handling, and MDR procedures. These issues indicate a broad lack of established procedures and documentation for ensuring the safety and quality of their Class IV New Era laser systems.