FDA Inspection 970472 — Miele & Cie. KG
The FDA completed an inspection of Miele & Cie. KG on April 25, 2016 in Oelde. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 25, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Oelde (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 5940 | 21 CFR 1030.10(c)(3)(i) | tests--errors and uncertainties accounted for |