# FDA 483 - CoreRX Inc. - March 06, 2020

Source: https://www.keypedia.com/records/483/corerx-inc/c5d7672d-dfb4-4e43-ac1d-b08c5c9efdb1

> FDA 483 for CoreRX Inc. on March 06, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CoreRX Inc.
- Inspection Date: 2020-03-06
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of CoreRX Inc., a contract manufacturer of prescription drugs in Clearwater, FL, revealed significant deficiencies in their quality systems, equipment qualification, and cleaning procedures. The firm failed to adequately investigate out-of-specification results, ensure equipment was properly designed and qualified, and establish sufficient procedures to prevent objectionable microorganisms. One critical observation regarding inadequate investigations was a repeat from a previous inspection.

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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