FDA Inspection
Italfarmaco S.p.A.Italfarmaco S.p.A. – FDA Inspection, Sep 18, 2018
Record Details
This FDA Inspection record concerns Italfarmaco S.p.A., with an inspection on September 18, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1938c577-14d3-4109-a07f-b62067e4e29a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065965
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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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 |
| March 13, 2015 | 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 919373 - 2015-03-13
- FDA Inspection 880378 - 2014-04-11
- FDA Inspection 753752 - 2011-10-28
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