FDA WARNING_LETTER - Innocore Sales & Marketing Inc. - April 25, 2025

The FDA issued a Warning Letter to The Tranzonic Companies/Innocore Sales & Marketing Inc. following an inspection from April 22 to 25, 2025. The letter outlined significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products under federal law. Key issues included the company"s failure to conduct adequate laboratory testing for finished drug products, specifically regarding the identity and strength of active ingredients and the absence of objectionable microorganisms prior to release. This meant a lack of scientific evidence that products met specifications.

Additionally, the company failed to perform sufficient identity testing on incoming drug components, particularly those at high risk for contamination with hazardous substances like diethylene glycol (DEG) and ethylene glycol (EG), which can be lethal.

Required actions by the FDA include a comprehensive, independent assessment of laboratory practices and a detailed remediation plan. The company must establish clear chemical and microbiological specifications for all products and provide an action plan for testing retain samples of distributed batches still within expiry, initiating recalls if quality issues are found. Immediate testing of high-risk components or finished products for DEG/EG contamination is required within 30 days. A thorough risk assessment for products potentially containing DEG/EG-prone ingredients is also mandated, alongside actions to secure supply chains, ensure component safety, and detail plans for robust component testing, including specific identity tests for every incoming lot.