483
Vitrolife, Inc.FDA 483 - Vitrolife, Inc. - February 13, 2019
Record Details
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.
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ID · 486d7fba-1308-4099-81fc-0e6f9788bdaa