FDA 483 - Intercos America Inc. - September 26, 2025

During an inspection conducted from September 22-26, 2025, Intercos America, Inc., an OTC Drug Packager located in West Nyack, NY, received an FDA Form 483 outlining significant observations related to its manufacturing and quality control practices. The inspection revealed that the company failed to fully follow its written stability testing program, specifically by not placing all required samples on stability and lacking ongoing annual stability studies for several OTC drug products as per its protocols. Additionally, Intercos America, Inc. did not routinely inspect and check its automatic, mechanical, and electronic equipment according to a written program designed to ensure proper performance, notably lacking completed performance qualification studies for key filling and packaging equipment. Lastly, the company's written procedures for annual product reviews (APRs) were found to be inadequate, missing required timeframes for completion, which resulted in many APRs for OTC drug products being delayed by several months. These observations indicate deficiencies in the company's adherence to Current Good Manufacturing Practices, necessitating prompt corrective actions to ensure compliance with federal regulations concerning drug product quality and safety.