Atlas

Form 483

Randall A. Ooms, Oomsview Holsteins Form 483, 2014-09-17

FDA issued a Form 483 to Randall A. Ooms, Oomsview Holsteins on 2014-09-17 with 3 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds3 observations

Randall A. Ooms, Oomsview Holsteins · Constable, United States · Issued September 17, 2014

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

17 Sep 2014
21 CFR 530.11(d)

Tissue residue

Cited by Tessa M Latham, Walter H Stanley, Tessa M Geary

17 Sep 2014
FDCA 402(a)(4)

Record keeping

Cited by Tessa M Latham, Walter H Stanley, Tessa M Geary

17 Sep 2014
FDCA 501(a)(5)

Expired drugs

Cited by Tessa M Latham, Walter H Stanley, Tessa M Geary

Inspected site

RARandall A. Ooms, Oomsview HolsteinsConstable, United States

Inspection team

TMTessa M Latham
WHWalter H Stanley
TMTessa M Geary

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 530.11(d)Cited across public-safe Form 483 observations1x
FDCA 402(a)(4)Cited across public-safe Form 483 observations1x
FDCA 501(a)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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