FDA EIR - Hovione LLC - January 22, 2020

An FDA inspection of Hovione LLC, a manufacturer of Active Pharmaceutical Ingredients and Intermediates, was conducted in East Windsor, NJ, from January 13 to January 22, 2020. This inspection covered both cGMP compliance and a Pre-Approval Inspection (PAI) for an undisclosed New Drug Application. The inspection identified significant deficiencies, leading to the issuance of an FDA-483. The primary violations included inadequate training for employees involved in cGMP activities, with numerous quality-related events attributed to a lack of knowledge or quality awareness, indicating ineffective training programs. Furthermore, the company failed to thoroughly investigate unexplained discrepancies, such as the use of incorrect or expired analytical solutions for product release, without adequately validating their impact on data accuracy. These issues directly relate to the regulatory frameworks of 21 CFR 211.25(a) concerning personnel qualification and 21 CFR 211.192 regarding investigation of discrepancies. Additional concerns raised during discussions included insufficient daily balance verifications, improper management of primary reference standards, and incomplete verification of electronic data backups, raising data integrity questions. Management also committed to improving chromatographic column tracking, documenting equipment calibration due dates, and implementing usage logs for all laboratory instruments. Hovione LLC's management pledged a written response and procedural corrections to address these observations, ensuring adherence to professional quality standards.