FDA Inspection 1222441 — ALS Pharma Ltda
The FDA completed an inspection of ALS Pharma Ltda on November 8, 2023 in Paulinia. 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
- November 8, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Paulinia (Brazil)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |