FDA 483 - Episciences Inc - January 29, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 45f24b5a-3fb6-4cbd-8425-19198c0410de