FDA Inspection 1191129 — Fischer ANalysen Instrumente GmbH
The FDA completed an inspection of Fischer ANalysen Instrumente GmbH on Nov 4, 2022 in Leipzig. 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
- Nov 4, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Leipzig (Germany)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |