Form 483

Linde Gas & Equipment Inc. Form 483, 2015-02-18

FDA issued a Form 483 to Linde Gas & Equipment Inc. on 2015-02-18 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Linde Gas & Equipment Inc. · Marlborough, United States · Issued February 18, 2015

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

18 Feb 2015
21 CFR 211.186(a)

Written procedures followed

Cited by Mary-Jeanet Mcgarry

18 Feb 2015
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Mary-Jeanet Mcgarry

18 Feb 2015
21 CFR 211.22(a)

Lack of quality control unit

Cited by Mary-Jeanet Mcgarry

18 Feb 2015
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Mary-Jeanet Mcgarry

Inspected site

LGLinde Gas & Equipment Inc.Marlborough, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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