FDA Inspection 1112956 — Hada International SAS
The FDA completed an inspection of Hada International SAS on Dec 12, 2019 in Barranquilla. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Barranquilla (Colombia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |