FDA Inspection 847869 — 2035 PMA
The FDA completed an inspection of 2035 PMA on September 13, 2013 in Rapid City, SD. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 13, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rapid City, SD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |