FDA Inspection 1328304 — Tenacore LLC
The FDA completed an inspection of Tenacore LLC on Jul 24, 2026 in Costa Mesa, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Costa Mesa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23034 | ISO 13485:2016 Clause 4.2.2 | Specific requirements of the Quality Manual not documented |
| 23129 | ISO 13485:2016 Clause 7.3.8 | Design and development transfer results or conclusions not recorded |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |