FDA Inspection
Italfarmaco S.A.Italfarmaco S.A. – FDA Inspection, Sep 15, 2023
Record Details
This FDA Inspection record concerns Italfarmaco S.A., with an inspection on September 15, 2023, issued by the Office of Inspections and Investigations.
- Company
- Italfarmaco S.A.
- Inspection Date
- September 15, 2023
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ID · 314e8be3-3769-43a7-9475-48b22abb50f3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1217769
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Italfarmaco S.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Italfarmaco S.A.
- FDA Inspection 1252373 - 2021-07-15
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