# FDA 483 - CoreRX Inc. - June 21, 2019

Source: https://www.keypedia.com/records/483/corerx-inc/4c534536-5911-42dd-8cf5-a28e860ef746

> FDA 483 for CoreRX Inc. on June 21, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CoreRX Inc.
- Inspection Date: 2019-06-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of CoreRx Inc. in Clearwater, FL, a drug product manufacturer, revealed three significant observations. The firm failed to establish scientifically sound test procedures for dissolution, did not maintain proper calibration records for equipment, and neglected to extend incident investigations to other relevant batches.

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## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)
- [Naveen B Kanthamneni](https://www.keypedia.com/people/naveen-b-kanthamneni/b6ac825f-1ec8-4857-b772-86ae2c6ea1cd)

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