Vitrolife, Inc. – FDA 483, Feb 13, 2019

During an inspection, Vitrolife, Inc., a medical device manufacturer in Englewood, CO, was cited for two significant issues. The firm failed to make required quality system records readily available for FDA review due to a viral infection affecting their automated systems. Additionally, the inspection revealed that process validation for sterilization equipment was not adequately documented or approved, with validation activities occurring before plan approval.