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Form 483

Baxter Healthcare Corporation Form 483, 2018-11-20

FDA issued a Form 483 to Baxter Healthcare Corporation on 2018-11-20 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Baxter Healthcare Corporation · Cleveland, United States · Issued November 20, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

20 Nov 2018
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Francis A Guidry

20 Nov 2018
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Francis A Guidry

Inspected site

BHBaxter Healthcare CorporationCleveland, United States

Inspection team

FAFrancis A Guidry

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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