FDA Inspection
Cardinal Health 414 LLCCardinal Health 414 LLC – FDA Inspection, Jul 1, 2025
Record Details
This FDA Inspection record concerns Cardinal Health 414 LLC, with an inspection on July 1, 2025, issued by the New England District Office, covering human drugs.
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ID · 7f9f99b0-6dca-4373-9699-4a7252c28939
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1274365
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 212.60(f)Lab written procedures
- 21 CFR 212.71(c)Correction of problems
- 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
- 21 CFR 212.50Adequate controls (general)
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Other FDA inspections of Cardinal Health 414 LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 8, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 13, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cardinal Health 414 LLC
- FDA Inspection 1093390 - 2019-06-18
- FDA Inspection 928691 - 2015-05-08
- FDA Inspection 707322 - 2011-01-13
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