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GC America, Inc. Warning Letter Details

Warning Letter

GC America, Inc.

Recipient Title President & Chief Operating Officer, GC America, Inc., 3737 West 127th Street Alsip , IL 60803 United States

Issue DateMay 14, 2026

FEI Number1410097

Violations6

CountryUnited States

Issuing Office

Center for Drug Evaluation and Research (CDER)

Product Type

Drugs

Status

Open

Subject

CGMP/Finished Pharmaceuticals/Adulterated

GC America, Inc. FDA Warning Letter, May 14, 2026