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FDA Inspection
•Alfasigma S.p.A.•June 21, 2018

Alfasigma S.p.A. – FDA Inspection, Jun 21, 2018

Record Details

This FDA Inspection record concerns Alfasigma S.p.A., with an inspection on June 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Alfasigma S.p.A.
Inspection Date
June 21, 2018
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Jose A. Cruz Gonzalez
View Company Profile

ID · d4b2f874-a493-482b-97a3-245817527523

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1056604
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of Alfasigma S.p.A.

5
DateClassificationOfficeProject area
January 26, 2024VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 28, 2021VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 30, 2017Not classifiedOffice of Inspections and Investigations
November 10, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 16, 2011VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Alfasigma S.p.A.
  • FDA Inspection 1293602 - 2024-01-26
  • FDA Inspection 1202245 - 2021-05-28
  • FDA Inspection 1023437 - 2017-06-30
  • FDA Inspection 951583 - 2015-11-10
  • FDA Inspection 748680 - 2011-09-16

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