FDA WARNING_LETTER - Integrity Partners Group - June 24, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Integrity Partners Group, following an inspection of its drug manufacturing facility, Chemisphere Corporation, from June 16 to 24, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering the company"s drug products adulterated. Key issues identified include the failure to perform essential laboratory testing on finished drug products before release. Specifically, the company did not adequately test over-the-counter (OTC) drug products for the strength of active ingredients or for microbiological contamination. This lack of testing means the company could not ensure products met quality specifications. Furthermore, the company failed to verify the identity of raw materials and high-risk components, such as glycerin, used in manufacturing. It relied on supplier certificates of analysis without proper validation, missing critical tests for hazardous impurities like diethylene glycol (DEG) and ethylene glycol (EG). The FDA deemed the company"s responses to these observations inadequate. Required actions include a comprehensive independent assessment of laboratory practices and a detailed plan to remediate and evaluate the effectiveness of the laboratory system. Integrity Partners Group must also conduct a thorough review of its material system, including supplier qualification and component testing. This involves establishing robust chemical and microbiological quality control specifications for all incoming materials and testing reserve samples of distributed products to ensure quality, with a mandate for rapid corrective actions, including recalls, if deficiencies are found.