FDA Inspection 798377 — Global Medical Holdings LLC
The FDA completed an inspection of Global Medical Holdings LLC on September 6, 2012 in Adel, IA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 6, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Adel, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |