FDA Inspection 630666 — Encore Medical, LP
The FDA completed an inspection of Encore Medical, LP on Oct 21, 2009 in Austin, 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 21, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |