FDA 483 - Fisher Wallace Laboratories Inc. - May 13, 2025

Fisher Wallace Laboratories Inc. in Brooklyn, NY, a manufacturer of Cranial Electrotherapy Stimulators, received a Form FDA 483 with six observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate control of non-conforming product, ineffective corrective and preventive actions, poor complaint handling, incomplete design verification, and insufficient supplier controls. Additionally, the firm failed to submit a required Medical Device Report for a serious injury in a timely manner.