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FDA Inspection
•Apotex Pharmachem Inc.•May 9, 2025

Apotex Pharmachem Inc. – FDA Inspection, May 9, 2025

Record Details

This FDA Inspection record concerns Apotex Pharmachem Inc., with an inspection on May 9, 2025, issued by the Office of Inspections and Investigations, covering human drugs.

Company
Apotex Pharmachem Inc.
Inspection Date
May 9, 2025
Product Type
Human Drugs
Office
Office of Inspections and Investigations
Person
  • Sean R. Marcsisin (FDA Associated Person)
View Company Profile

ID · 2efffc38-5aba-4fb7-bc7d-bc309a632259

Inspection Facts

Inspection number
1269863
FDA center
Human Drugs
Outcome
Form 483 issued

Other FDA inspections of Apotex Pharmachem Inc.

5
DateClassificationOfficeProject area
December 16, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 24, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
December 2, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 21, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 3, 2012NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Apotex Pharmachem Inc.
  • FDA Inspection 1194792 - 2022-12-16
  • FDA Inspection 1095165 - 2019-05-24
  • FDA Inspection 1002803 - 2016-12-02
  • FDA Inspection 905258 - 2014-11-21
  • FDA Inspection 769352 - 2012-02-03

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