Form 483

Rangen, LLC Form 483, 2009-06-11

FDA issued a Form 483 to Rangen, LLC on 2009-06-11 with 3 public-safe observations.

483· Form 483 issued3 observations

Rangen, LLC · Buhl, United States · Issued June 11, 2009

Overview

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

Inspectional observations

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

11 Jun 2009
21 CFR 589.2000(d)(1)

Protein blenders, feed manufacturers, distributors

Cited by John W Banks, Michael F Schuette

11 Jun 2009
21 CFR 589.2000(e)(1)

Separate equipment and facilities

Cited by John W Banks, Michael F Schuette

11 Jun 2009
21 CFR 589.2000(e)(1)

Written product separation procedures

Cited by John W Banks, Michael F Schuette

Inspected site

RLRangen, LLCBuhl, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 589.2000(e)(1)Cited across public-safe Form 483 observations2x
21 CFR 589.2000(d)(1)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 3 observations

The source PDF and 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