FDA Inspection 921149 — Meditech KFT
The FDA completed an inspection of Meditech KFT on January 15, 2015 in Budapest. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 15, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Budapest (Hungary)
Citations
| ID | CFR | Description |
|---|---|---|
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |