# FDA 483 - Cardinal Health 414 LLC - February 06, 2026

Source: https://www.keypedia.com/records/483/cardinal-health-414-llc/3eb6366d-31b5-4cbb-be4b-a6de1ac59b1a

> FDA 483 for Cardinal Health 414 LLC on February 06, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardinal Health 414 LLC
- Inspection Date: 2026-02-06
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Cardinal Health 414 LLC in Tampa, FL, a PET drug manufacturer, was cited for significant quality system deficiencies. Observations included failures to establish and follow written quality assurance procedures, inadequate corrective actions for nonconforming products, and incomplete investigations into sterility out-of-specification results. Additionally, complaint records lacked essential information regarding the nature and follow-up of adverse events.

## Related Documents

- [483 - 2018-11-08](https://www.keypedia.com/records/483/cardinal-health-414-llc/ace5d5e1-10dc-4b55-aaaf-4ccb2ee28109)
- [483 - 2026-02-06](https://www.keypedia.com/records/483/cardinal-health-414-llc/0a39be14-d06d-4d98-aba0-deb64a2ffee9)

## Related Officers

- [Dorothy P. Kramer](https://www.keypedia.com/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.keypedia.com/companies/cardinal-health-414-llc/ac29a561-71ff-41a6-86b1-cfd314da6b33

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6