FDA 483 - Fisher Wallace Laboratories Inc. - March 15, 2023

Fisher Wallace Laboratories Inc. in Brooklyn, NY, was inspected and received 11 observations related to significant deficiencies in their quality system for manufacturing Fisher Wallace Stimulators. The observations highlight issues across design control, complaint handling, MDR reporting, supplier management, and record keeping, indicating a broad lack of adherence to medical device regulations. The firm failed to adequately establish and follow procedures for design plans, MDR reporting, complaint investigations, incoming product acceptance, control over contractors, CAPA, design changes, and record keeping.