Ft. Recovery Equity, Inc.

Form 483 issued March 24, 2011 · Ft. Recovery, Ohio

Inspection
Aug 11, 2010 – Mar 3, 2011
Observations
4
Pages
3
FEI number
1520332

In short: On March 24, 2011, FDA issued a Form 483 with 4 observations to Ft. Recovery Equity, Inc. in Ft. Recovery, Ohio (FEI 1520332) after an inspection that ran Aug 11, 2010 – Mar 3, 2011. The investigator was Michael M. Kelleher. The most-cited regulation is 21 CFR 118.4 (salmonella Enteritidis (SE) prevention measures).

What FDA observed

Preview: the opening words of each observation

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

  1. 01

    Failure to test the pullet environment for Salmonella Enteritidis (SE) during the required time period of…

  2. 02

    Failure to include provisions in your written SE prevention plan aimed at preventing the introduction or…

  3. 03

    Failure to include provisions your written SE prevention plan…

  4. 04

    Failure to have a site specific written SE prevention plan for each farm…

The full 483

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

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This inspection in context

Questions about this 483

What did FDA find at Ft. Recovery Equity, Inc.?

FDA listed 4 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 Ft. Recovery Equity, Inc.?

Michael M. Kelleher is named on this Form 483, for the inspection of Aug 11, 2010 – Mar 3, 2011. Each investigator has a profile showing what they cite most.

When was Ft. Recovery Equity, Inc. inspected by FDA?

The inspection ran Aug 11, 2010 – Mar 3, 2011, and the Form 483 is dated March 24, 2011.

How do I get the full Form 483 for Ft. Recovery Equity, Inc.?

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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