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FDA Inspection
•Unimark Remedies Limited•September 29, 2017

Unimark Remedies Limited – FDA Inspection, Sep 29, 2017

Record Details

This FDA Inspection record concerns Unimark Remedies Limited, with an inspection on September 29, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Unimark Remedies Limited
Inspection Date
September 29, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Erika V. Butler (FDA Associated Person)
  • Tsedenia Woldehanna (Issuing Officer)
View Company Profile

ID · b7a4fa70-1a5d-4dfd-832f-f0cb9c484b5e

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1030008
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of Unimark Remedies Limited

3
DateClassificationOfficeProject area
May 22, 2015OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 4, 2013VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 25, 2009VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Unimark Remedies Limited
  • FDA Inspection 934553 - 2015-05-22
  • FDA Inspection 821526 - 2013-03-04
  • FDA Inspection 619161 - 2009-09-25

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