# FDA 483 - Cardinal Health 200, LLC - December 20, 2023

Source: https://www.keypedia.com/records/483/cardinal-health-200-llc/12d7fffe-2038-48f4-97eb-e37f2569c56b

> FDA 483 for Cardinal Health 200, LLC on December 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardinal Health 200, LLC
- Inspection Date: 2023-12-20
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Cardinal Health 200, LLC in Waukegan, IL, revealed significant deficiencies in their quality system for medical devices. Observations included inadequate corrective and preventive action procedures, insufficient controls over purchased products and suppliers, and sampling plans not based on valid statistical rationale. These issues primarily concerned Monojet Syringes and could lead to device failures and patient harm.

## Related Officers

- [investigator](https://www.keypedia.com/people/laiza-v-garcia/d24e0890-a153-4d8a-9c74-2cc2f2773192)

Company: https://www.keypedia.com/companies/cardinal-health-200-llc/7396619a-c77d-4266-91ca-2351b1ec359c

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669