FDA Inspection
Sianco S.A.Sianco S.A. – FDA Inspection, Aug 17, 2018
Record Details
This FDA Inspection record concerns Sianco S.A., with an inspection on August 17, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · ede534aa-2ec3-4f57-bbad-7f403d493488
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062414
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
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