Form 483

Airgas USA, LLC Form 483, 2013-05-22

FDA issued a Form 483 to Airgas USA, LLC on 2013-05-22 with 11 public-safe observations.

483· Form 483 issuedHuman Drugs11 observations

Airgas USA, LLC · Billerica, United States · Issued May 22, 2013

Overview

  • 11 public-safe observations are available for this inspection.
  • 11 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.

22 May 2013
21 CFR 211.22(c)

Approve or reject procedures or specs

Cited by Philip Kreiter

22 May 2013
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Philip Kreiter

22 May 2013
21 CFR 211.56(b)

Written sanitation procedures lacking

Cited by Philip Kreiter

22 May 2013
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Philip Kreiter

22 May 2013
21 CFR 211.80(b)

Handling and Storage to Prevent Contamination

Cited by Philip Kreiter

Inspected site

AUAirgas USA, LLCBillerica, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.150(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.80(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 11 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