FDA Intel

Sparboe Farms Inc.

Form 483 issued May 19, 2011 · Eagle Grove, Iowa

Inspection
May 16 – May 19, 2011
Investigators
Brittany D. Phillips· Collins M. Mason· Kathleen J. Klier
Observations
4
Pages
2
FEI number
3007754995

In short: On May 19, 2011, FDA issued a Form 483 with 4 observations to Sparboe Farms Inc. in Eagle Grove, Iowa (FEI 3007754995) after an inspection that ran May 16 – May 19, 2011. The investigators were Brittany D. Phillips, Collins M. Mason, Kathleen J. Klier, Kevin E. Klommhaus, Lloyd Krutzfeldt, Neal Vaughn and Shaun M. Olson. 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
    21 CFR 118.4

    Your written SE prevention plan lacks…

  2. 02
    21 CFR 118.10

    All required records do not include your name and the…

  3. 03
    21 CFR 118.10

    All required records do not have the signature or initials of the person performing the operation…

  4. 04
    21 CFR 118.4

    You lack adequate review of records created to document…

The full 483

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

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This inspection in context

The investigator

Brittany D. Phillips

6 documents · 2011

Cites 118.4 (salmonella enteritidis (se) prevention measures) more than any other section. Most of their documents are for sites in Iowa.

The firm

Sparboe Farms Inc. history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 118.4

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Sparboe Farms 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 Sparboe Farms Inc.?

Brittany D. Phillips, Collins M. Mason, Kathleen J. Klier, Kevin E. Klommhaus, Lloyd Krutzfeldt, Neal Vaughn and Shaun M. Olson are named on this Form 483, for the inspection of May 16 – May 19, 2011. Each investigator has a profile showing what they cite most.

When was Sparboe Farms Inc. inspected by FDA?

The inspection ran May 16 – May 19, 2011, and the Form 483 is dated May 19, 2011.

How do I get the full Form 483 for Sparboe Farms Inc.?

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