FDA Inspection
Cardinal Health 200, LLCCardinal Health 200, LLC – FDA Inspection, Dec 20, 2023
Record Details
This FDA Inspection record concerns Cardinal Health 200, LLC, with an inspection on December 20, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b72cf4ac-1b5d-414b-9270-cad8d8825484
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1225568
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Cardinal Health 200, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2025 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| May 5, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 25, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 22, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cardinal Health 200, LLC
- FDA Inspection 1291588 - 2025-10-30
- FDA Inspection 1204987 - 2023-05-05
- FDA Inspection 984851 - 2016-08-25
- FDA Inspection 703400 - 2010-12-22
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