FDA Inspection
Italfarmaco S.p.A.Italfarmaco S.p.A. – FDA Inspection, Mar 13, 2015
Record Details
This FDA Inspection record concerns Italfarmaco S.p.A., with an inspection on March 13, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Italfarmaco S.p.A.
- Inspection Date
- March 13, 2015
- Product Type
- Drugs
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ID · 1640ef28-79db-4e7c-a7d5-62391dcd60b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 919373
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Italfarmaco S.p.A.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 1, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 18, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 11, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 28, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Italfarmaco S.p.A.
- FDA Inspection 1250897 - 2023-06-28
- FDA Inspection 1123970 - 2019-02-01
- FDA Inspection 1065965 - 2018-09-18
- FDA Inspection 880378 - 2014-04-11
- FDA Inspection 753752 - 2011-10-28
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