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FDA Inspection
•Cardinal Health 414, LLC•September 25, 2024

Cardinal Health 414, LLC – FDA Inspection, Sep 25, 2024

Record Details

This FDA Inspection record concerns Cardinal Health 414, LLC, with an inspection on September 25, 2024, issued by the Denver District Office, covering human drugs.

Company
Cardinal Health 414, LLC
Inspection Date
September 25, 2024
Product Type
Human Drugs
Office
Denver District Office
Person
  • Nicholas L. Hunt (FDA Associated Person)
View Company Profile

ID · 10f5cc0d-cc22-4a6f-90bd-3c7b8694fe56

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1250133
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 212.61(a)Stability testing program
  2. 21 CFR 212.20(e)Written QA procedures established, followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Cardinal Health 414, LLC

1
DateClassificationOfficeProject area
September 17, 2014NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Cardinal Health 414, LLC
  • FDA Inspection 895748 - 2014-09-17

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