Warning letter

IIT Research Institute: warning letter of Dec 5, 2005

FDA warning letter UCM075728 · Center for Drug Evaluation and Research

Key facts

Reference number UCM075728
Company IIT Research Institute
Subject GLP for non-clincal laboratory studies
Issue date Dec 5, 2005
Posted date Dec 5, 2005
Issuing office Center for Drug Evaluation and Research
Product type Drugs
CFR sections cited 58, 58.3(o), 58.31(d), 58.120(a), 58.120(a)(11), 58.130(a), 58.130(e), 58.185(a)(4), 58.185(a)(9)
Country 3
Inspection city Chicago
Inspection ZIP 60616-3717
Inspection start date Jan 3, 2005
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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