Atlas

Form 483

Airgas USA, LLC Form 483, 2017-05-09

FDA issued a Form 483 to Airgas USA, LLC on 2017-05-09 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Airgas USA, LLC · Billerica, United States · Issued May 9, 2017

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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 May 2017
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Sean R Marcsisin

9 May 2017
21 CFR 211.165(e)

Test methods

Cited by Sean R Marcsisin

9 May 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Sean R Marcsisin

Inspected site

AUAirgas USA, LLCBillerica, United States

Inspection team

SRSean R Marcsisin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
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