FDA Inspection
Sintetica S.A.Sintetica S.A. – FDA Inspection, May 17, 2019
Record Details
This FDA Inspection record concerns Sintetica S.A., with an inspection on May 17, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b82a0fb9-4880-4cd9-b28b-45cffb291516
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095637
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Sintetica S.A.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 6, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 28, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sintetica S.A.
- FDA Inspection 1244013 - 2023-11-09
- FDA Inspection 1002397 - 2016-12-06
- FDA Inspection 907553 - 2014-11-21
- FDA Inspection 807676 - 2012-11-09
- FDA Inspection 697847 - 2010-10-28
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