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FDA Inspection
•Contract Pharmaceutical Services of Australia Pty Ltd•February 13, 2014

Contract Pharmaceutical Services of Australia Pty Ltd – FDA Inspection, Feb 13, 2014

Record Details

This FDA Inspection record concerns Contract Pharmaceutical Services of Australia Pty Ltd, with an inspection on February 13, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Contract Pharmaceutical Services of Australia Pty Ltd
Inspection Date
February 13, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 2fb09c4a-0351-4031-8af9-c5569fb4e1ab

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
873771
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

2
  1. 21 CFR 211.22(a)Authority lacking to review records, investigate errors
  2. 21 CFR 211.111Establishment of time limitations

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Contract Pharmaceutical Services of Australia Pty Ltd

2
DateClassificationOfficeProject area
November 1, 2012OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 26, 2009VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Contract Pharmaceutical Services of Australia Pty Ltd
  • FDA Inspection 807619 - 2012-11-01
  • FDA Inspection 623902 - 2009-10-26

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