FDA Inspection 685179 — Bauer & Haselbarth - Chirurg GmbH
The FDA completed an inspection of Bauer & Haselbarth - Chirurg GmbH on Sep 16, 2010 in Ellerau. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 16, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ellerau (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 537 | 21 CFR 820.70(a) | Production processes |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |