FDA Inspection 566043 — Sunrise Medical US, LLC
The FDA completed an inspection of Sunrise Medical US, LLC on Feb 9, 2009 in Indianapolis, IN. 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
- Feb 9, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3398 | 21 CFR 820.80(d)(3) | No release signature |
| 3399 | 21 CFR 820.80(d)(4) | No release authorization date |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |