Atlas

Form 483

Linde Gas & Equipment Inc. Form 483, 2014-06-19

FDA issued a Form 483 to Linde Gas & Equipment Inc. on 2014-06-19 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Linde Gas & Equipment Inc. · Twinsburg, United States · Issued June 19, 2014

Overview

  • 2 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.

19 Jun 2014
21 CFR 211.160(b)(4)

Establishment of calibration procedures

Cited by Karen M Kondas

19 Jun 2014
21 CFR 211.165(a)

Testing and release for distribution

Cited by Karen M Kondas

Inspected site

LGLinde Gas & Equipment Inc.Twinsburg, United States

Inspection team

KMKaren M Kondas

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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