FDA Inspection 670941 — Andreas Hettich Gmbh & Co. Kg
The FDA completed an inspection of Andreas Hettich Gmbh & Co. Kg on June 17, 2010 in Tuttlingen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 17, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tuttlingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2481 | 21 CFR 820.30(c) | Design input procedures - addressing conflicting requirement |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4071 | 21 CFR 820.30(i) | Design changes - validation vs. verification |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |