FDA Inspection 1301182 — Tesla Biohealing, Inc.
The FDA completed an inspection of Tesla Biohealing, Inc. on Apr 16, 2026 in Milford, DE. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 16, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Milford, DE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22801 | 21 CFR 830.310(b) | GUDID Information required for unique device identification. |
| 23056 | ISO 13485:2016 Clause 5.5.1 | Interrelation of personnel not documented |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23121 | ISO 13485:2016 Clause 7.3.7 | Design and development validation plans not adequate |
| 23132 | ISO 13485:2016 Clause 7.3.9 | Design and development changes not identified |
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |
| 23205 | ISO 13485:2016 Clause 7.6 | Software used for monitoring and measurement not validated |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |