FDA Inspection
Sintetica S.A.Sintetica S.A. – FDA Inspection, Dec 6, 2016
Record Details
This FDA Inspection record concerns Sintetica S.A., with an inspection on December 6, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4a674cf6-b70b-484b-9114-c9f74485eeaa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002397
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.94(b)Protection from external factors
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
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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 |
| 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 1095637 - 2019-05-17
- FDA Inspection 907553 - 2014-11-21
- FDA Inspection 807676 - 2012-11-09
- FDA Inspection 697847 - 2010-10-28
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