Atlas

Form 483

Baxter Corporation Form 483, 2019-09-17

FDA issued a Form 483 to Baxter Corporation on 2019-09-17 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Baxter Corporation · Alliston, Canada · Issued September 17, 2019

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.

17 Sep 2019
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Alice S Tsao

17 Sep 2019
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Alice S Tsao

Inspected site

BCBaxter CorporationAlliston, Canada

Inspection team

ASAlice S Tsao

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, 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