FDA Inspection 1146624 — Encore Medical, L.P.
The FDA completed an inspection of Encore Medical, L.P. on Jul 20, 2021 in Cedar Park, TX. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 20, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cedar Park, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |