FDA Inspection 1121765 — Devon Orthopaedic Implants LLC.,
The FDA completed an inspection of Devon Orthopaedic Implants LLC., on Mar 23, 2020 in King Of Prussia, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 23, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |