FDA Inspection 680230 — Generic Medical Devices, Inc.
The FDA completed an inspection of Generic Medical Devices, Inc. on September 9, 2010 in Gig Harbor, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 9, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Gig Harbor, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |