FDA Inspection 895604 — Laboratorio Magnachem International, S.A.
The FDA completed an inspection of Laboratorio Magnachem International, S.A. on Sep 16, 2014 in Haina. 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
- Sep 16, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Haina (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |