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

Bear-Ent, Llc, a medical device manufacturer in Malvern, PA, was inspected by the FDA and received a Form 483 with seven observations. The inspection revealed significant deficiencies in the firm's quality management system, including failures to maintain 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.