FDA Inspection
Laboratorio Magnachem International, S.A.Laboratorio Magnachem International, S.A. – FDA Inspection, Sep 16, 2014
Record Details
This FDA Inspection record concerns Laboratorio Magnachem International, S.A., with an inspection on September 16, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 16, 2014
- Product Type
- Drugs
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ID · fe07d6ba-a29e-4647-bc69-e203baa1249d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 895604
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Laboratorio Magnachem International, S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 2, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 27, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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