Atlas

Form 483

Airgas USA, LLC Form 483, 2017-04-26

FDA issued a Form 483 to Airgas USA, LLC on 2017-04-26 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Airgas USA, LLC · Grand Junction, United States · Issued April 26, 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.

26 Apr 2017
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Nayan J Patel

26 Apr 2017
21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by Nayan J Patel

26 Apr 2017
21 CFR 211.198(a)

Procedures to be written and followed

Cited by Nayan J Patel

Inspected site

AUAirgas USA, LLCGrand Junction, United States

Inspection team

NJNayan J Patel

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 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)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