University of Illinois @ Urbana - Champaign

Form 483 issued July 11, 2015 · Illinois

Observations
3
Pages
1
FEI number
3003925188

In short: On July 11, 2015, FDA issued a Form 483 with 3 observations to University of Illinois @ Urbana - Champaign in Illinois (FEI 3003925188). The most-cited regulation is 21 CFR 511.1 (new animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act).

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 511.1

    Failure to adequately monitor INADs submitted to FDA/CVM as follows: The university has failed to adequately…

  2. 02
    21 CFR 511.1

    The firm conducted an investigation of hogs and piglets since April 2004 without…

  3. 03
    21 CFR 511.1

    Unauthorized rendering of a subject…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at University of Illinois @ Urbana - Champaign?

FDA listed 3 observations on this Form 483. The most-cited regulation is 21 CFR 511.1 (new animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act). The opening words of each observation are shown on this page.

When was University of Illinois @ Urbana - Champaign inspected by FDA?

This Form 483 is dated July 11, 2015.

How do I get the full Form 483 for University of Illinois @ Urbana - Champaign?

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