FDA EIR - Lusomedicamenta Sociedade Tecnica Farmaceutica S.A - September 27, 2019

An FDA Pre-Approval Inspection (PAI) and current Good Manufacturing Practices (cGMP) inspection of Lusomedicamenta Sociedade Tecnica Farmaceutica S.A. was conducted from September 23 to September 27, 2019. This inspection, requested by the Center for Veterinary Medicine (CVM), aimed to assess the company's readiness for commercial manufacturing, conformance to application, and data integrity for SurolanTM Otic Solution (NADA # 141298), alongside a comprehensive review of all six GMP systems. The regulatory framework included Compliance Programs 7368.001 for animal drugs in feeds and 7356.002 for drug manufacturing. The inspection concluded with the issuance of a five-item FDA-483, detailing significant observations. Key issues identified were an inadequate calibration procedure, deficiencies in raw material sample collection, failure to follow established process control procedures, unapproved changes to procedures not sanctioned by the client as per quality agreements, and restored electronic data not being reviewed according to schedule. In response, company management acknowledged these observations, committed to implementing necessary corrections, and pledged to submit a detailed written response within fifteen working days. The FDA's recommendation is to approve NADA 141298, with a classification of Voluntary Action Indicated (VAI), suggesting a re-inspection based on a scheduled workplan or sooner if deemed necessary.