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Form 483

Becton Dickinson Infusion Therapy Systems, Inc. Form 483, 2026-03-26

FDA issued a Form 483 to Becton Dickinson Infusion Therapy Systems, Inc. on 2026-03-26 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Becton Dickinson Infusion Therapy Systems, Inc. · Sandy, United States · Issued March 26, 2026

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

26 Mar 2026
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Shanna N Purdy, Demario L Walls

26 Mar 2026
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Shanna N Purdy, Demario L Walls

26 Mar 2026
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Shanna N Purdy, Demario L Walls

Inspected site

BDBecton Dickinson Infusion Therapy Systems, Inc.Sandy, United States

Inspection team

SNShanna N Purdy
DLDemario L Walls

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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