Atlas

Form 483

Rangen, LLC Form 483, 2018-03-01

FDA issued a Form 483 to Rangen, LLC on 2018-03-01 with 2 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds2 observations

Rangen, LLC · Buhl, United States · Issued March 1, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

1 Mar 2018
21 CFR 225.42(b)

Adequate procedures established

Cited by Alicia A Borg-Borm

1 Mar 2018
21 CFR 225.58(b)(1)

First batch assay

Cited by Alicia A Borg-Borm

Inspected site

RLRangen, LLCBuhl, United States

Inspection team

AAAlicia A Borg-Borm

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 225.42(b)Cited across public-safe Form 483 observations1x
21 CFR 225.58(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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