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FDA Inspection
•Mipharm S.p.A.•September 22, 2023

Mipharm S.p.A. – FDA Inspection, Sep 22, 2023

Record Details

This FDA Inspection record concerns Mipharm S.p.A., with an inspection on September 22, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Mipharm S.p.A.
Inspection Date
September 22, 2023
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Rajiv R. Srivastava (FDA Associated Person)
View Company Profile

ID · cc148a53-3099-4984-9987-6d1113bbbb60

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1219480
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of Mipharm S.p.A.

5
DateClassificationOfficeProject area
October 17, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 3, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 14, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 27, 2013VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 10, 2011NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Mipharm S.p.A.
  • FDA Inspection 1133100 - 2019-10-17
  • FDA Inspection 1004998 - 2017-02-03
  • FDA Inspection 870680 - 2014-02-14
  • FDA Inspection 853837 - 2013-09-27
  • FDA Inspection 731940 - 2011-06-10

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