FDA 483 - Episciences Inc - January 29, 2024

During an inspection conducted from January 22 to January 29, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Episciences Inc., a drug manufacturer located in Boise, ID. The document details five significant observations indicating deviations from current Good Manufacturing Practices (cGMP). Key violations included the absence of a written stability testing program for their OTC drug product, "Daily Shield Tinted SPF50," resulting in products being shipped without data to support their expiry dates. Inspectors also noted deficient procedures for cleaning and maintaining shared manufacturing equipment, specifically for a mixer and a hopper, which are used for both cosmetic and drug products without proper validation to prevent cross-contamination; this was a repeat observation from a previous inspection. Further concerns involved the firm's failure to test incoming components, such as "Glycerine," for potential high-risk contaminants before use, which was also a repeat observation. Additionally, access to labels and labeling materials for the "Daily Shield Tinted SPF50" product was not adequately controlled, and batch records lacked distinctive identification numbers for major equipment used in manufacturing. Episciences Inc. is required to provide a response outlining their comprehensive corrective and preventive actions to address these serious deficiencies.