FDA Inspection 942749 — Therasage, LLC.
The FDA completed an inspection of Therasage, LLC. on September 18, 2015 in San Marcos, TX. 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
- September 18, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Marcos, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |