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FDA Inspection
•Adare Pharmaceuticals Srl•February 24, 2017

Adare Pharmaceuticals Srl – FDA Inspection, Feb 24, 2017

Record Details

This FDA Inspection record concerns Adare Pharmaceuticals Srl, with an inspection on February 24, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Adare Pharmaceuticals Srl
Inspection Date
February 24, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Jessica P. Mcalister (FDA Associated Person)
View Company Profile

ID · 75dde054-ec24-489f-a35c-ec53c5804795

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1006241
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 211.160(b)(3)Drug product sample

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Adare Pharmaceuticals Srl

5
DateClassificationOfficeProject area
October 28, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 13, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 30, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 19, 2012NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 9, 2009VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Adare Pharmaceuticals Srl
  • FDA Inspection 1204801 - 2022-10-28
  • FDA Inspection 1098299 - 2018-04-13
  • FDA Inspection 883317 - 2014-05-30
  • FDA Inspection 793805 - 2012-07-19
  • FDA Inspection 622477 - 2009-10-09

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