FDA Inspection 773877 — Beurer North America, LLC
The FDA completed an inspection of Beurer North America, LLC on Mar 26, 2012 in Hollywood, FL. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 26, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hollywood, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |