FDA 483 - Mohnark Pharmaceuticals Inc - February 25, 2022

An FDA inspection of Mohnark Pharmaceuticals Inc, an OTC drug manufacturer in Davie, FL, revealed significant deficiencies across multiple areas. The firm was cited for lacking adequate quality control procedures, failing to properly test raw materials, and maintaining incomplete production records. Additionally, issues were noted regarding inadequate dust control equipment and unsuitable building construction, indicating a lack of current Good Manufacturing Practices.