FDA Flags Cross-Contamination Risks at US OTC Manufacturer

Following a June 2026 inspection, the US Food and Drug Administration (FDA) issued a Warning Letter to Integrity Partners Group, an over-the-counter (OTC) drug manufacturer, citing serious cross-contamination risks between pharmaceutical and non-pharmaceutical production.

The agency found that the company had not established adequate cleaning and maintenance procedures for shared manufacturing equipment. OTC medicines were produced on non-dedicated equipment also used for non-pharmaceutical products, and the FDA determined that the cleaning validation data did not sufficiently demonstrate the removal of residues. According to the regulator, such practices pose a significant contamination risk and fall short of current Good Manufacturing Practice (GMP) standards.

Although the manufacturer proposed a site-wide cleaning validation master plan, the FDA deemed the response inadequate. The agency noted the absence of a retrospective risk assessment for previously manufactured products and criticised the lack of interim safeguards before validation is completed.

The FDA has called for comprehensive corrective actions, including strengthened validation protocols, formal risk assessments, clearly defined CAPA measures, and improved documentation to protect product quality and patient safety.

11-02-2026