FDA 483 - Entopsis , Inc. - December 06, 2022

An FDA inspection of Entopsis, Inc. in Medley, FL, revealed significant deficiencies across its quality system. The firm failed to validate critical manufacturing processes, software, and equipment, indicating a broad lack of control over its PCRopsis product production. Additionally, inadequate procedures for acceptance activities, complaint handling, supplier qualification, and document control were observed, highlighting systemic issues in maintaining compliance with regulatory requirements.