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

An FDA inspection conducted at GCAmerican, an OTC drug manufacturer located in Alsip, Illinois, from November 4 to November 7, 2025, revealed several significant deficiencies in their manufacturing and quality control operations. The inspection report, known as an FDA Form 483, highlighted critical issues requiring prompt corrective action to ensure compliance with Current Good Manufacturing Practices. A primary concern was the lack of appropriate controls over computer systems and data integrity. The firm's QC lab utilized equipment allowing unrestricted access to analytical data, with passwords displayed and data not automatically saved, leading to potential loss or unauthorized alteration. Manual data transfers lacked proper quality unit review. Furthermore, a packaging line printer lacked user authentication, and equipment changes, such as a probe replacement, were undocumented and unverified by the quality assurance unit. Additional observations included the absence of a written procedure for annual product reviews, a fundamental aspect of a robust quality system. Critically, GCAmerican failed to establish adequate stability data for their OTC drug products, with no studies conducted since 2022, thus lacking scientific evidence to support expiration dating claims. Lastly, the inspection found that the company did not perform adequate testing of water used in drug manufacturing, only monitoring conductivity, without crucial chemical and microbiological evaluations. GCAmerican is required to implement comprehensive corrective and preventive actions to address these observations, ensuring the integrity of their data, the quality of their products, and adherence to all applicable regulatory standards.