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Form 483

Baxter Healthcare Corporation Form 483, 2022-06-09

FDA issued a Form 483 to Baxter Healthcare Corporation on 2022-06-09 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Baxter Healthcare Corporation · Deerfield, United States · Issued June 9, 2022

Overview

  • 1 public-safe observation is 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.

9 Jun 2022
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jesse A Vazquez

Inspected site

BHBaxter Healthcare CorporationDeerfield, United States

Inspection team

JAJesse A Vazquez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 1 observation

The source PDF, 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