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# ‘Objectionable Conditions’ at Chicago Cornea
- URL: https://www.fdaweb.com/objectionable-conditions-at-chicago-cornea/
- Published: 2023-06-21T12:00:00.000Z
- Updated: 2026-09-14T18:40:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154731

A 9/19-10/26/2022 FDA inspection at Chicago Cornea Consultants in Highland Park, IL, found “objectionable conditions” in the conduct of two clinical investigations. A 6/14 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/randy-j-epstein-mdchicago-cornea-consultants-ltd-658917-06142023?ref=fdaweb.com) says the inspection was part of the agency’s Bioresearch Monitoring Program. The Warning Letter says specific violations were:

- failing to submit an IND for the conduct of a clinical investigation with investigational new drugs; and
- failing to maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug.

Chicago Cornea CEO **Randy Epstein** was told to respond with a list of actions he has taken to prevent similar violations in the future.