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FDA Inspection
•Apotex Corp.•August 10, 2011

Apotex Corp. – FDA Inspection, Aug 10, 2011

Record Details

This FDA Inspection record concerns Apotex Corp., with an inspection on August 10, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Apotex Corp.
Inspection Date
August 10, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · debc8709-db96-4fc2-b63a-69c5c2c789de

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
738828
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

1
  1. 21 CFR 314.80(c)(1)(i)Late submission of 15-day report

Full citation text and observation details available on the Dashboard.

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