FDA 483 - American Regent, Inc. - January 25, 2019

HBT Labs, Inc. in Brea, CA, underwent an FDA inspection from January 7-25, 2019, regarding its manufacturing of Paclitaxel Albumin Bound Bulk Suspension. The inspection revealed significant deficiencies across multiple areas, including inadequate method validation, data integrity issues, incomplete batch and master production records, lack of written procedures for critical processes, and failures in quality control unit responsibilities and supplier qualification. These findings indicate a broad lack of adherence to cGMP requirements, posing potential risks to drug product quality and purity.