FDA Inspection 1208362 — Theos Medical Systems, Inc.
The FDA completed an inspection of Theos Medical Systems, Inc. on June 16, 2023 in Santa Clara, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 16, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Santa Clara, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4060 | 21 CFR 820.20(b)(3)(i) | Management representative implementing the quality system |