Atlas

Form 483

Aurolife Pharma LLC Form 483, 2011-05-25

FDA issued a Form 483 to Aurolife Pharma LLC on 2011-05-25 with 3 public-safe observations.

483· Form 483 issued3 observations

Aurolife Pharma LLC · Dayton, United States · Issued May 25, 2011

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.

25 May 2011
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Justine Tomasso

25 May 2011
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Justine Tomasso

25 May 2011
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Justine Tomasso

Inspected site

APAurolife Pharma LLCDayton, United States

Inspection team

JTJustine Tomasso

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.22(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