FDA Inspection 753025 — Bauer & Haselbarth - Chirurg GmbH
The FDA completed an inspection of Bauer & Haselbarth - Chirurg GmbH on Sep 15, 2011 in Ellerau. 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
- Sep 15, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ellerau (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |