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Form 483

Baxter Healthcare Corporation Form 483, 2016-09-13

FDA issued a Form 483 to Baxter Healthcare Corporation on 2016-09-13 with 5 public-safe observations.

483· Form 483 issuedHuman Drugs5 observations

Baxter Healthcare Corporation · Aibonito, United States · Issued September 13, 2016

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

13 Sep 2016
21 CFR 211.182

Written records kept in individual logs

Cited by Noreen Muniz

13 Sep 2016
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Noreen Muniz

13 Sep 2016
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Noreen Muniz

13 Sep 2016
21 CFR 211.52

Washing and toilet facilities are deficient

Cited by Noreen Muniz

13 Sep 2016
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Noreen Muniz

Inspected site

BHBaxter Healthcare CorporationAibonito, United States

Inspection team

NMNoreen Muniz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.52Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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