FDA 483 - NeuroField, Inc. - June 23, 2023

NeuroField, Inc. in Bishop, CA, a manufacturer/specification developer, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies across multiple quality system areas, including purchasing controls, software validation, CAPA procedures, design history file establishment, document control, and nonconforming product control. These issues indicate a systemic lack of adequately established and maintained procedures, posing a moderate to severe risk to product quality and regulatory compliance.