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# Objectionable Study Conditions at Corona Doctors Medical
- URL: https://www.fdaweb.com/objectionable-study-conditions-at-corona-doctors-medical/
- Published: 2018-11-28T12:00:00.000Z
- Updated: 2026-09-15T00:47:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142907

A 6/22-6/27 FDA inspection at Corona Doctors Medical Clinics, Corona, CA, found objectionable conditions in the clinic’s role as the sponsor of a redacted clinical investigation. An 11/16 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm626614.htm?ref=fdaweb.com) says the inspection was conducted as a part of FDA’s Bioresearch Monitoring Program. Specific issues emphasized in the letter were: 

- violating a clinical hold by giving subjects an investigational drug after FDA issued an order to delay a proposed clinical investigation; and
- administration of an investigational new drug to human subjects without an effective IND.

The letter says the clinic should address the deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations. Corona was told to respond with a list of actions taken to prevent similar violations in the future.