FDA Inspection 585222 — Sandstone Medical Technologies LLC
The FDA completed an inspection of Sandstone Medical Technologies LLC on May 26, 2009 in Birmingham, AL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- May 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Birmingham, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3156 | 21 CFR 820.181(b) | DMR production process specifications |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |