FDA Inspection
Sintetica S.A.Sintetica S.A. – FDA Inspection, Nov 21, 2014
Record Details
This FDA Inspection record concerns Sintetica S.A., with an inspection on November 21, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sintetica S.A.
- Inspection Date
- November 21, 2014
- Product Type
- Drugs
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ID · b47a1e66-f62d-4a2d-a954-240c0a91eb2d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 907553
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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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 |
| May 17, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 6, 2016 | 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 1095637 - 2019-05-17
- FDA Inspection 1002397 - 2016-12-06
- FDA Inspection 807676 - 2012-11-09
- FDA Inspection 697847 - 2010-10-28
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