FDA Inspection 917327 — Global Surgical
The FDA completed an inspection of Global Surgical on Mar 10, 2015 in Saint Louis, MO. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 10, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4208 | 21 CFR 806.20(a) | Records not kept |