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Integrity Partners Group's manufacturing facility failed to adequately test over-the-counter drug products for active ingredient strength (assay) and microbiological contamination prior to release and distribution, violating Current Good Manufacturing Practice (CGMP) requirements under 21 CFR 211.165(a) and (b). The FDA inspection of the Chemisphere Corporation facility in Saint Louis, Missouri from June 16-24, 2025 determined that these testing deficiencies rendered the finished drug products adulterated. Without appropriate pre-release testing to verify identity, strength, quality, and purity, the company could not ensure its drug products conformed to predetermined quality standards and were safe for their intended use.