# FDA 483 - Cardinal Biologicals, Inc. - May 09, 2025

Source: https://www.keypedia.com/records/483/cardinal-biologicals-inc/ee691394-c3ce-4c1f-8447-665aed2149ed

> FDA 483 for Cardinal Biologicals, Inc. on May 09, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardinal Biologicals, Inc.
- Inspection Date: 2025-05-09
- Product Type: biologics
- Office Name: Kansas City District Office
- Summary: Cardinal Biologicals, Inc. in Cape Girardeau, MO, an HCT/P establishment, was cited for six observations during an FDA inspection. The findings primarily concern inadequate record-keeping for equipment use and cleaning, lack of environmental monitoring, and improper handling and labeling of human birth tissues, particularly those pending donor eligibility. These issues indicate a failure to prevent contamination and ensure product safety.

## Related Officers

- [Esther A. Ofori](https://www.keypedia.com/people/esther-a-ofori/98108fae-1e09-4849-bceb-18e69dff7ba4)
- [Amy A. Johnson](https://www.keypedia.com/people/amy-a-johnson/9933f793-503f-45c5-8837-d46134c20e09)
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Company: https://www.keypedia.com/companies/cardinal-biologicals-inc/0afeaaa1-90e2-4642-9bf5-95bc060e9127

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79