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FDA Inspection
•Alfresa Fine Chemical Corporation•February 8, 2019

Alfresa Fine Chemical Corporation – FDA Inspection, Feb 8, 2019

Record Details

This FDA Inspection record concerns Alfresa Fine Chemical Corporation, with an inspection on February 8, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Alfresa Fine Chemical Corporation
Inspection Date
February 8, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Junho Pak (FDA Associated Person)
View Company Profile

ID · 27cf472d-de99-4374-8dcf-8b7fe557c706

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1079693
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of Alfresa Fine Chemical Corporation

3
DateClassificationOfficeProject area
April 8, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 6, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 30, 2009VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Alfresa Fine Chemical Corporation
  • FDA Inspection 971668 - 2016-04-08
  • FDA Inspection 887640 - 2014-06-06
  • FDA Inspection 614710 - 2009-07-30

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