FDA Inspection 1171331 — Devon Orthopaedic Implants LLC.,
The FDA completed an inspection of Devon Orthopaedic Implants LLC., on May 19, 2022 in King Of Prussia, PA. 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
- May 19, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- King Of Prussia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |