FDA Inspection 905523 — STOCKERT GMBH
The FDA completed an inspection of STOCKERT GMBH on November 13, 2014 in Freiburg Im Breisgau. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 13, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Freiburg Im Breisgau (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |