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FDA Inspection
•Judith Ratzan•September 13, 2010

Judith Ratzan – FDA Inspection, Sep 13, 2010

Record Details

This FDA Inspection record concerns Judith Ratzan, with an inspection on September 13, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Judith Ratzan
Inspection Date
September 13, 2010
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · ac54996c-db1a-4246-a87b-85bce8918f66

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
672813
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

3
  1. 21 CFR 312.60FD-1572, protocol compliance
  2. 21 CFR 312.62(b)Case history records- inadequate or inadequate
  3. 21 CFR 312.64(b)Safety reports

Full citation text and observation details available on the Dashboard.

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