FDA 483 - Bear-Ent, Llc - February 26, 2026

An FDA inspection of Bear-Ent, Llc, a medical device manufacturer in Malvern, PA, revealed significant deficiencies in their quality management system. The firm failed to maintain adequate records for risk management, complaint handling, process validation, infrastructure maintenance, supplier evaluation, management reviews, and internal audits. These issues indicate a systemic lack of adherence to established procedures and regulatory requirements for medical device manufacturing.