FDA Inspection 741729 — Orthopedic Alliance LLC
The FDA completed an inspection of Orthopedic Alliance LLC on September 23, 2011 in Murrieta, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 23, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Murrieta, CA (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 |
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |