FDA Inspection 1102457 — Milla d.o.o.
The FDA completed an inspection of Milla d.o.o. on September 18, 2019 in Grad Zagreb. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 18, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grad Zagreb (Croatia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |