FDA Inspection 841967 — Global Medical Holdings LLC
The FDA completed an inspection of Global Medical Holdings LLC on July 19, 2013 in Adel, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Adel, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |