FDA 483 - LifeCell Corporation - August 25, 2017

LifeCell Corporation in Branchburg, NJ, was inspected, revealing several deficiencies in its quality system for the Revolve System device. The inspection cited inadequate process validation for cleaning and endotoxin testing, along with failures in document control, acceptance activities, supplier evaluation, and corrective and preventive action procedures. These observations indicate a need for the firm to strengthen its adherence to established quality protocols.