FDA Inspection 1055382 — ALS Czech Republic, S.R.O.
The FDA completed an inspection of ALS Czech Republic, S.R.O. on May 29, 2018 in Prague 9. 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
- May 29, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Prague 9 (Czech Republic)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |