FDA Inspection 1065580 — Aap Biomaterials, GmbH
The FDA completed an inspection of Aap Biomaterials, GmbH on Sep 6, 2018 in Dieburg. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 6, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dieburg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |