Form 483 · FEI 3008778967

Form 483 issued June 29, 2011 · Fremont, Iowa

Inspection
Jun 23 – Jun 29, 2011
Observations
10
Pages
4
FEI number
3008778967

In short: On June 29, 2011, FDA issued a Form 483 with 10 observations to an FDA-inspected site in Fremont, Iowa (FEI 3008778967) after an inspection that ran Jun 23 – Jun 29, 2011. The investigators were Brittany D. Phillips and Kathleen J. Close. The most-cited regulation is 21 CFR 118.4 (salmonella Enteritidis (SE) prevention measures).

What FDA observed

Preview: the opening words of each observation
  1. 01

    Your poultry house was not cleaned and disinfected by appropriate procedures before new laying hens were…

  2. 02

    Environmental testing tor SE, using approved methods, was not done in a poultry house when any…

  3. 03

    The poultry house environmental sampl ing plan was not appropriate to…

  4. 04

    Observation 4: scanned text, readable in the full document.

6 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at an FDA-inspected site?

FDA listed 10 observations on this Form 483. The most-cited regulation is 21 CFR 118.4 (salmonella Enteritidis (SE) prevention measures). The opening words of each observation are shown on this page.

Who inspected an FDA-inspected site?

Brittany D. Phillips and Kathleen J. Close are named on this Form 483, for the inspection of Jun 23 – Jun 29, 2011. Each investigator has a profile showing what they cite most.

When was an FDA-inspected site inspected by FDA?

The inspection ran Jun 23 – Jun 29, 2011, and the Form 483 is dated June 29, 2011.

How do I get the full Form 483 for an FDA-inspected site?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.

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