Form 483

Cardinal Health 414 LLC Form 483, 2025-07-01

FDA issued a Form 483 to Cardinal Health 414 LLC on 2025-07-01 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Cardinal Health 414 LLC · East Hartford, United States · Issued July 1, 2025

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

1 Jul 2025
21 CFR 212.30(a)

Orderly handling, prevention of mix-ups, prevention of contamination

Cited by Jonathan G Matrisciano, Erik W Koester

1 Jul 2025
21 CFR 212.50

Adequate controls (general)

Cited by Jonathan G Matrisciano, Erik W Koester

1 Jul 2025
21 CFR 212.60(f)

Lab written procedures

Cited by Jonathan G Matrisciano, Erik W Koester

1 Jul 2025
21 CFR 212.71(c)

Correction of problems

Cited by Jonathan G Matrisciano, Erik W Koester

Inspected site

CHCardinal Health 414 LLCEast Hartford, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 212.30(a)Cited across public-safe Form 483 observations1x
21 CFR 212.50Cited across public-safe Form 483 observations1x
21 CFR 212.60(f)Cited across public-safe Form 483 observations1x
21 CFR 212.71(c)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 4 observations

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