# FDA 483 - Cardinal Health 418, Inc. - February 21, 2020

Source: https://www.keypedia.com/records/483/cardinal-health-418-inc/16462835-69a1-4b39-8bbf-66535266ca6c

> FDA 483 for Cardinal Health 418, Inc. on February 21, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardinal Health 418, Inc.
- Inspection Date: 2020-02-21
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Cardinal Health 418, Inc. in Aurora, CO, a pharmaceutical manufacturer, revealed significant deficiencies in equipment maintenance and cleaning validation practices. Inspectors observed poorly maintained equipment with residues and rust, and found that the firm lacked adequate cleaning procedures and a robust cleaning validation study for its manufacturing equipment. These issues raise concerns about the control over manufacturing processes and the quality of drug products.

## Related Officers

- [Zachary A. Bogorad](https://www.keypedia.com/people/zachary-a-bogorad/ae582dcd-f893-44a5-98bd-0b55f401577b)

Company: https://www.keypedia.com/companies/cardinal-health-418-inc/86385c39-f27c-4ce4-bb8d-cda5d4450812

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face