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

Source: https://www.keypedia.com/records/warning_letter/innovative-neurotronic-inc/13ecc8e1-ddf3-4403-8930-5bb4bf027e40

> FDA WARNING_LETTER for Innovative Neurotronic, Inc. on September 04, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Innovative Neurotronic, Inc.
- Inspection Date: 2008-09-04
- Product Type: Devices
- Office Name: Dallas District Office
- Summary: 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.

## Related Officers

- [District Director](https://www.keypedia.com/people/reynaldo-rodriguez/6e765ccb-f28d-433b-85cb-eafb8b8c35df)

Company: https://www.keypedia.com/companies/innovative-neurotronic-inc/030efad2-5363-4db1-b44b-72ea25364283

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9