Aspen Pharma Trading Ltd. – FDA Inspection, Sep 20, 2017

Record Details

This FDA Inspection record concerns Aspen Pharma Trading Ltd., with an inspection on September 20, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Aspen Pharma Trading Ltd.
Inspection Date: September 20, 2017
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Angela E. Glenn (Issuing Officer)

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ID · fc2155f4-1774-4ae3-acdb-cdf41a65f285

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1026371
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

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

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FDA Inspection

Aspen Pharma Trading Ltd.September 20, 2017