FDA Inspection
Truer Medical IncTruer Medical Inc – FDA Inspection, Feb 13, 2026
Record Details
This FDA Inspection record concerns Truer Medical Inc, with an inspection on February 13, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.
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ID · 01f2f9c1-b803-4ec1-ae5d-61be3c048fca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1302690
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
1- ISO 13485:2016 Clause 7.3.10Design and development files not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Truer Medical Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 20, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 15, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Truer Medical Inc
- FDA Inspection 1209973 - 2023-06-28
- FDA Inspection 1119121 - 2020-02-20
- FDA Inspection 887884 - 2014-07-15
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