FDA Inspection
Organo Sintesis, S.A. De C.V.Organo Sintesis, S.A. De C.V. – FDA Inspection, Jul 28, 2023
Record Details
This FDA Inspection record concerns Organo Sintesis, S.A. De C.V., with an inspection on July 28, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4de42ed2-d325-42b0-b74a-0d0cf17f3aef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1218259
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Organo Sintesis, S.A. De C.V.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 25, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Organo Sintesis, S.A. De C.V.
- FDA Inspection 995619 - 2016-08-05
- FDA Inspection 809281 - 2012-10-25
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