FDA Inspection
S.I.P.R.E.S. SrlS.I.P.R.E.S. Srl – FDA Inspection, Jan 23, 2025
Record Details
This FDA Inspection record concerns S.I.P.R.E.S. Srl, with an inspection on January 23, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 587b6f19-de52-4e1e-9144-5e28bbeb4d4f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1259898
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of S.I.P.R.E.S. Srl
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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