Atlas

Form 483

Randall A. Ooms, Oomsview Holsteins Form 483, 2016-03-02

FDA issued a Form 483 to Randall A. Ooms, Oomsview Holsteins on 2016-03-02 with 3 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds3 observations

Randall A. Ooms, Oomsview Holsteins · Constable, United States · Issued March 2, 2016

Overview

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

Inspectional observations

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

2 Mar 2016
21 CFR 530.11(d)

Tissue residue

Cited by Dana A Razzano

2 Mar 2016
21 CFR 530.11(a)

Rx not followed

Cited by Dana A Razzano

2 Mar 2016
FDCA 402(a)(4)

Record keeping

Cited by Dana A Razzano

Inspected site

RARandall A. Ooms, Oomsview HolsteinsConstable, United States

Inspection team

DADana A Razzano

Cited regulations

CFR citations associated with this Form 483.

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