FDA Inspection 636913 — Encompass Group LLC
The FDA completed an inspection of Encompass Group LLC on December 22, 2009 in Mcdonough, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 22, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mcdonough, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3330 | 21 CFR 820.181(d) | DMR packaging and labeling specifications |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4189 | 21 CFR 820.198(a) | General |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |