FDA Inspection 782783 — Laboratorio Magnachem International, S.A.
The FDA completed an inspection of Laboratorio Magnachem International, S.A. on Apr 27, 2012 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
- Apr 27, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Haina (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |