Genzyme Ltd. – FDA Inspection, Aug 6, 2009

Record Details

This FDA Inspection record concerns Genzyme Ltd., with an inspection on August 6, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Genzyme Ltd.
Inspection Date: August 6, 2009
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · b6d266e3-6542-4d06-8b14-e95efca3dbe9

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 610013
FDA center: Human Drugs
Project area: Bioresearch Monitoring

FDA Citations

21 CFR 600.80(c)(1)(i)Reporting Requirements - 15-day alert

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FDA Inspection

Genzyme Ltd.August 6, 2009