FDA Inspection 1106700 — MANDELAY KFT
The FDA completed an inspection of MANDELAY KFT on October 17, 2019 in Tokol. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 17, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tokol (Hungary)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |