FDA 483 - Episciences Inc - January 29, 2024

Episciences Inc. in Boise, ID, was inspected and cited for significant deficiencies in its manufacturing processes for the OTC drug product "Daily Shield Tinted SPF50." Key issues include the absence of a stability testing program, inadequate cleaning validation for shared equipment, and failure to test incoming components for contaminants. Additionally, the firm was cited for unsecured labeling materials and incomplete batch records regarding equipment identification.