FDA Inspection
Cardinal Health 414, Inc.Cardinal Health 414, Inc. – FDA Inspection, Jan 25, 2018
Record Details
This FDA Inspection record concerns Cardinal Health 414, Inc., with an inspection on January 25, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b3a385ab-049e-49d1-81bc-24724c9b6ea2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1038753
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.50Adequate controls (general)
- 21 CFR 212.60(c)Analytical methods
- 21 CFR 212.10Personnel not qualified
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Other FDA inspections of Cardinal Health 414, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2025 | VAI | Seattle District Office | Drug Quality Assurance |
| February 25, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 3, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 14, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 17, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cardinal Health 414, Inc.
- FDA Inspection 1273848 - 2025-06-13
- FDA Inspection 1118917 - 2020-02-25
- FDA Inspection 961781 - 2015-11-03
- FDA Inspection 810926 - 2012-12-14
- FDA Inspection 582328 - 2009-04-17
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