Atlas

Form 483

The Aurum Group, LLC Form 483, 2014-01-31

FDA issued a Form 483 to The Aurum Group, LLC on 2014-01-31 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

The Aurum Group, LLC · El Paso, United States · Issued January 31, 2014

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.

31 Jan 2014
21 CFR 1271.260(e)

Storage temperatures recorded, maintained

Cited by Young M Yoon, Hector Cerros

31 Jan 2014
21 CFR 1271.265(e)

Documentation elements for activities

Cited by Young M Yoon, Hector Cerros

31 Jan 2014
21 CFR 1271.265(e)

Procedures and release criteria

Cited by Young M Yoon, Hector Cerros

Inspected site

TAThe Aurum Group, LLCEl Paso, United States

Inspection team

YMYoung M Yoon
HCHector Cerros

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.265(e)Cited across public-safe Form 483 observations2x
21 CFR 1271.260(e)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