FDA Inspection 650411 — ARJ Medical, Inc. / Gulf Coast Scientific Inc
The FDA completed an inspection of ARJ Medical, Inc. / Gulf Coast Scientific Inc on March 9, 2010 in Tampa, FL. 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
- March 9, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 4189 | 21 CFR 820.198(a) | General |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |