FDA 483 - BPI Labs LLC - April 23, 2025

During an inspection from April 14-23, 2025, BPI Labs, LLC in Largo, FL, was cited for failing to ensure mechanisms were in place for healthcare providers to complete the certification process as required by their approved REMS Element to Assure Safe Use (ETASU) A. This included deficiencies in disseminating information via emails, website banners, and hard copy mailings to targeted audiences within specified timelines. The firm demonstrated a significant lack of compliance in implementing critical safety measures.