Neurotrack Technologies – FDA Inspection, Mar 25, 2026

Record Details

This FDA Inspection record concerns Neurotrack Technologies, with an inspection on March 25, 2026, issued by the San Francisco District Office, covering medical devices & rad health.

Company: Neurotrack Technologies
Inspection Date: March 25, 2026
Product Type: Medical Devices & Rad Health
Office: San Francisco District Office
Person: Kwong P. Lee (Company Rep)

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ID · e7e9518d-075d-4d88-b415-cff51d0d8234

Inspection Facts

Inspection number: 1309246
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.3.7Design and development validation not conducted on representative product
ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
ISO 13485:2016 Clause 8.5.2Corrective action records not maintained

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FDA Inspection

Neurotrack TechnologiesMarch 25, 2026