FDA Inspection 610839 — G3 Medical, Inc. dba G3 Packaging
The FDA completed an inspection of G3 Medical, Inc. dba G3 Packaging on August 24, 2009 in Asheville, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 24, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Asheville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |