# FDA 483 - CoreRX Inc. - January 24, 2014

Source: https://www.globalkeysolutions.net/records/483/corerx-inc/ab98b6ba-9be2-497c-bee5-bc2f3c60eef0

> FDA 483 for CoreRX Inc. on January 24, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CoreRX Inc.
- Inspection Date: 2014-01-24
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of CoreRx Inc. in Clearwater, FL, revealed significant deficiencies in equipment design and qualification, investigation procedures, process control, and equipment calibration. The firm failed to ensure manufacturing equipment suitability, conduct thorough investigations into discrepancies, justify deviations from procedures, and maintain proper calibration records for critical equipment. These issues indicate a lack of adequate quality control and compliance with manufacturing standards.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/mizanne-e-lewis/c79964ac-5163-44a2-89e9-8cc8775de9b4)
- [Approval Manager](https://www.globalkeysolutions.net/people/michael-h-tollon/5e30e7e1-5727-4169-8faf-e5d5783ac781)

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

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