FDA Inspection
Cardinal Health 414, LLCCardinal Health 414, LLC – FDA Inspection, Jul 31, 2025
Record Details
This FDA Inspection record concerns Cardinal Health 414, LLC, with an inspection on July 31, 2025, issued by the Florida District Office, covering human drugs.
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ID · a617fd7a-22dc-476c-8344-eb3a5b7d988e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1277070
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- FD&C Act 501(a)(2)(A)Personnel, blocked or disrupted first air
- FD&C Act 501(a)(2)(A)Lack of disinfection, equipment/supplies from lower to higher quality air
- 21 CFR 212.71(c)Correction of problems
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.71(b)Documentation of Non-Conforming Product Investigation
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Other FDA inspections of Cardinal Health 414, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 17, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 10, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 26, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 15, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cardinal Health 414, LLC
- FDA Inspection 1069934 - 2018-10-26
- FDA Inspection 930723 - 2015-06-17
- FDA Inspection 718155 - 2011-03-10
- FDA Inspection 653785 - 2010-03-26
- FDA Inspection 582372 - 2009-05-15
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