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

Source: https://www.keypedia.com/records/483/corerx-inc/4e925761-65a5-468e-a5d9-c170685d7857

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

---

## Details

- Record Type: 483
- Company Name: CoreRX Inc.
- Inspection Date: 2025-03-20
- Product Type: biologics
- Office Name: Florida District Office
- Summary: CoreRX Inc. in Clearwater, FL, a biologic drug manufacturer, received a Form 483 with six observations highlighting significant deficiencies in their manufacturing operations. Issues include inadequate written procedures for production controls, insufficient investigation of discrepancies, poor equipment cleaning and facility maintenance, and failures in quality control unit procedures and material storage. These findings indicate a lack of robust controls to ensure drug product quality and integrity.

## Related Documents

- [483 - 2014-01-24](https://www.keypedia.com/records/483/corerx-inc/ab98b6ba-9be2-497c-bee5-bc2f3c60eef0)
- [483 - 2019-06-14](https://www.keypedia.com/records/483/corerx-inc/7f68df2f-6919-4a4a-9d5d-425416d88e52)
- [483 - 2019-06-21](https://www.keypedia.com/records/483/corerx-inc/4c534536-5911-42dd-8cf5-a28e860ef746)
- [483 - 2020-03-06](https://www.keypedia.com/records/483/corerx-inc/c5d7672d-dfb4-4e43-ac1d-b08c5c9efdb1)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9