Form 483

Agropur, Inc. Form 483, 2009-09-28

FDA issued a Form 483 to Agropur, Inc. on 2009-09-28 with 6 public-safe observations.

483· Form 483 issued6 observations

Agropur, Inc. · Le Sueur, United States · Issued September 28, 2009

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

28 Sep 2009
21 CFR 110.20(b)(2)

Contamination with microorganisms, chemicals, filth, etc.

Cited by Sandra Sejdinovic, Karla J Youngberg, Theresa C Klaman

28 Sep 2009
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Sandra Sejdinovic, Karla J Youngberg, Theresa C Klaman

28 Sep 2009
21 CFR 110.35(d)(3)

Non-food-contact surfaces (S)

Cited by Sandra Sejdinovic, Karla J Youngberg, Theresa C Klaman

28 Sep 2009
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Sandra Sejdinovic, Karla J Youngberg, Theresa C Klaman

28 Sep 2009
21 CFR 110.40(a)

Materials and workmanship

Cited by Sandra Sejdinovic, Karla J Youngberg, Theresa C Klaman

Inspected site

AIAgropur, Inc.Le Sueur, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere