FDA 483 - Surmasis Pharmaceutical, LLC - August 01, 2025

Surmasis Pharmaceutical, LLC in Des Moines, IA, a combination drug/device manufacturer, received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including a repeat observation regarding the investigation of unexplained discrepancies. Additionally, the firm failed to segregate non-conforming materials and lacked proper management review and a written quality plan for its combination products.