FDA Inspection 896628 — G3 Medical, Inc. dba G3 Packaging
The FDA completed an inspection of G3 Medical, Inc. dba G3 Packaging on September 19, 2014 in Asheville, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 19, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Asheville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |