FDA Inspection 779021 — Lek D.D.
The FDA completed an inspection of Lek D.D. on Apr 6, 2012 in Ljubljana. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 6, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ljubljana (Slovenia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |