FDA WARNING_LETTER - Innovative Neurotronic, Inc. - September 04, 2008

An FDA inspection of Innovative Neurotronics, Inc. in August-September 2008 found their WalkAide™ System adulterated, non-compliant with Quality System (QS) regulation (21 CFR Part 820) CGMP requirements. The firm's FDA 483 response was incomplete, lacking a formal quality plan and verified effectiveness. Key violations included: inadequate evaluation of contractors for quality (21 CFR § 820.50(a)), despite product complaints and recalls; insufficient corrective and preventive action (CAPA) procedures and verification (21 CFR § 820.100(a)(3), (a)(4), (b)), evidenced by unverified rework and incomplete investigations for issues like inverted stimulation and cable breakage; failure to establish procedures for documenting, approving, verifying, or validating specification/process changes (21 CFR § 820.70(b)), causing device malfunctions from an invalidated PCB change; lack of procedures for design change identification, documentation, verification, and approval (21 CFR § 820.30(i)), especially for "temporary deviations"; and absence of established procedures for rework, retesting, and reevaluation of nonconforming products (21 CFR § 820.90(b)(2)), with no specific documentation for reworked recalled devices. The FDA requires prompt written corrective action within 15 working days, with documentation and a timetable. Non-compliance risks regulatory actions (seizure, injunctions, penalties), impacts federal contracts, and affects pre-market approvals or export certificates. The letter suggests potential systemic quality assurance problems.