FDA 483 - Topical Pharmaceuticals, Inc. - May 07, 2026

Topical Pharmaceuticals, Inc. in Addison, IL, was cited for numerous deficiencies during an FDA inspection, primarily concerning its quality control unit and manufacturing processes. The firm demonstrated a lack of adequate written procedures for critical operations, including out-of-specification investigations, third-party laboratory qualification, and process validation. Significant issues were also noted in equipment design, environmental controls, component testing, and the completeness and review of batch production records, indicating systemic failures in maintaining drug product quality and purity.