# FDA 483 - CoreRX Inc. - June 14, 2019

Source: https://www.globalkeysolutions.net/records/483/corerx-inc/7f68df2f-6919-4a4a-9d5d-425416d88e52

> FDA 483 for CoreRX Inc. on June 14, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CoreRX Inc.
- Inspection Date: 2019-06-14
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: CoreRx, Inc. in Clearwater, FL, was inspected by the FDA, revealing several deficiencies in quality control, facility maintenance, and documentation practices. Observations included unqualified test methods, uncalibrated balances, poor cleanroom drainage, inadequate cleaning records, and insufficient temperature and humidity control in the warehouse. Additionally, procedures for receiving temperature-sensitive materials were found to be inadequate.

## Related Documents

- [483 - 2014-01-24](https://www.globalkeysolutions.net/records/483/corerx-inc/ab98b6ba-9be2-497c-bee5-bc2f3c60eef0)
- [483 - 2019-06-21](https://www.globalkeysolutions.net/records/483/corerx-inc/4c534536-5911-42dd-8cf5-a28e860ef746)
- [483 - 2020-03-06](https://www.globalkeysolutions.net/records/483/corerx-inc/c5d7672d-dfb4-4e43-ac1d-b08c5c9efdb1)
- [483 - 2025-03-20](https://www.globalkeysolutions.net/records/483/corerx-inc/4e925761-65a5-468e-a5d9-c170685d7857)

## Related Officers

- [Jennifer Bridgewater, Assoc. Dir. for Reg. Policy](https://www.globalkeysolutions.net/people/jennifer-bridgewater-assoc-dir-for-reg-policy/573a7b9f-6b6d-427c-9893-2b5a3b758ed0)
- [Laura Fortun, CSO](https://www.globalkeysolutions.net/people/laura-fortun-cso/66af427d-5dc3-4270-97b5-376dd1b55cf7)
- [Philippa Hillyer, Staff Fellow](https://www.globalkeysolutions.net/people/philippa-hillyer-staff-fellow/e3876e45-cdc9-48fb-ae65-2387b94ef949)
- [Gregory Price, Biologist](https://www.globalkeysolutions.net/people/gregory-price-biologist/eba2ffa9-c31a-46ac-b4d6-08c2dc410305)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd