483
Surmasis Pharmaceutical, LLCSurmasis Pharmaceutical, LLC – FDA 483, Aug 1, 2025
Record Details
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.
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ID · a9754776-fa7b-407d-9e77-3850f1791576
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