Compliance Update Allergenic Products Advisory Committee Meeting March 5, 2001

2/26/01


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Table of Contents

Compliance Update Allergenic Products Advisory Committee Meeting March 5, 2001

Enforcement Actions

Enforcement Actions

Enforcement Actions Allergenic Product Manufacturers

Inspection vs. Enforcement FY99

Inspection vs. Enforcement FY00

FY01 Enforcement Actions

Inspection vs. Enforcement FY01

Biological Product Deviations

Biologic Product Deviation Reports

Precipitates

Recalls

Allergenic Product Recalls

Most Frequent Issues ® Enforcement Actions -1999-2001

Continued...

Continued….

Improvement Noted

Forward Thinking

Forward Thinking ..cont...

Further Information

Author: FDA