FDA 483 - GC America, Inc. - November 07, 2025

GC America Inc., an OTC drug manufacturer in Alsip, Illinois, was inspected and received a Form 483 with four observations. The inspection revealed significant issues with data integrity and computer system controls, including unrestricted access and lack of data backup for analytical instruments, and inadequate controls for product packaging printers. Additionally, the firm failed to conduct annual product reviews, lacked a stability testing program to support product expiration dates, and did not adequately test water used in drug product manufacturing for microbiological specifications.