FDA Inspection
CareFusion 213, LLCCareFusion 213, LLC – FDA Inspection, Dec 15, 2016
Record Details
This FDA Inspection record concerns CareFusion 213, LLC, with an inspection on December 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f072b06f-072e-4160-83a7-3f0968baebdc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 997744
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of CareFusion 213, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2025 | OAI | Dallas District Office | Drug Quality Assurance |
| September 29, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 11, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 8, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 3, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for CareFusion 213, LLC
- FDA Inspection 1288506 - 2025-10-24
- FDA Inspection 1219336 - 2023-09-29
- FDA Inspection 871049 - 2014-03-11
- FDA Inspection 818062 - 2013-02-08
- FDA Inspection 729730 - 2011-06-03
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