FDA Inspection
Tenacore LLCTenacore LLC – FDA Inspection, Jul 24, 2026
Record Details
This FDA Inspection record concerns Tenacore LLC, with an inspection on July 24, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.
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ID · 151b522d-023a-4743-b312-081332a76a60
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1328304
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 4.2.2Specific requirements of the Quality Manual not documented
- ISO 13485:2016 Clause 7.3.8Design and development transfer results or conclusions not recorded
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Tenacore LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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