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FDA Inspection
•Alchem International Ltd.•September 15, 2017

Alchem International Ltd. – FDA Inspection, Sep 15, 2017

Record Details

This FDA Inspection record concerns Alchem International Ltd., with an inspection on September 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Alchem International Ltd.
Inspection Date
September 15, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Brian D. Nicholson (FDA Associated Person)
View Company Profile

ID · 43024a66-e959-4887-aea2-87e9f45d5e32

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1028256
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of Alchem International Ltd.

5
DateClassificationOfficeProject area
July 4, 2025Not classifiedOffice of Inspections and Investigations
September 6, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 1, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 11, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 8, 2009NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Alchem International Ltd.
  • FDA Inspection 1279310 - 2025-07-04
  • FDA Inspection 1101273 - 2019-09-06
  • FDA Inspection 964030 - 2016-04-01
  • FDA Inspection 790556 - 2012-07-11
  • FDA Inspection 629985 - 2009-10-08

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