Atlas

Form 483

Rangen, LLC Form 483, 2010-07-09

FDA issued a Form 483 to Rangen, LLC on 2010-07-09 with 3 public-safe observations.

483· Form 483 issued3 observations

Rangen, LLC · Buhl, United States · Issued July 9, 2010

Overview

  • 3 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.

9 Jul 2010
21 CFR 225.58(d)

Assay results out of specification

Cited by Michael F Schuette

9 Jul 2010
21 CFR 225.58(e)

Distribution discontinued

Cited by Michael F Schuette

9 Jul 2010
21 CFR 225.58(e)

Subsequent production

Cited by Michael F Schuette

Inspected site

RLRangen, LLCBuhl, United States

Inspection team

MFMichael F Schuette

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 225.58(e)Cited across public-safe Form 483 observations2x
21 CFR 225.58(d)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