# FDA 483 - CoreRX Inc. - March 20, 2025

Source: https://www.keypedia.com/records/483/corerx-inc/edfc4c2a-ac55-4dee-8c2f-122fff2c1404

> FDA 483 for CoreRX Inc. on March 20, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CoreRX Inc.
- Inspection Date: 2025-03-20
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: CoreRX Inc. in Clearwater, FL, a biologic drug manufacturer, was cited with six observations during an FDA inspection from March 12-20, 2025. The inspection revealed significant deficiencies in production and process controls, quality control unit procedures, equipment cleaning, discrepancy investigations, facility maintenance, and material storage. These issues indicate a lack of adherence to established written procedures and proper control over manufacturing operations.

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- [483 - 2020-03-06](https://www.keypedia.com/records/483/corerx-inc/c5d7672d-dfb4-4e43-ac1d-b08c5c9efdb1)
- [483 - 2025-03-20](https://www.keypedia.com/records/483/corerx-inc/4e925761-65a5-468e-a5d9-c170685d7857)

## Related Officers

- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)
- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.keypedia.com/companies/corerx-inc/cca4f858-9ccd-498a-893b-22c5d29559aa

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