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

During an FDA inspection conducted from November 3-7, 2025, at GC America Inc., an OTC drug manufacturer located in Alsip, Illinois, several significant issues were observed. The inspection revealed inadequate controls over computer systems and related data. Specifically, analytical instruments allowed unrestricted access and data deletion without proper backups or quality unit review. Furthermore, a printer used for product identification lacked user accountability for lot and expiration date entry, and equipment replacement lacked proper investigation and approval. The company also failed to perform annual product reviews for its drug products since 2018 and lacked a written standard operating procedure for such reviews. A crucial observation highlighted the absence of a written stability testing program. This resulted in insufficient stability data for paste products, with expiration dates supported only by an inadequate accelerated aging study, lacking real-time data. Lastly, the inspection found that GC America Inc. lacked procedures to prevent objectionable microorganisms in non-sterile drug products, failing to adequately test water used in manufacturing for chemical and microbiological specifications. These observations indicate a need for comprehensive corrective actions to ensure compliance with quality standards for drug manufacturing.