779894
GHC Healthcare Inc. — FEI 1000140469
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 20, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Alpharetta, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |