FDA 483 - CTL Medical Corporation

An FDA inspection of CTL Medical Corporation, a medical device manufacturer in Addison, TX, from August 30 to September 3, 2021, revealed significant deficiencies in their quality system. Observations included inadequate procedures for controlling nonconforming product, specifically lacking investigations and risk analysis determinations for numerous nonconformances. Additionally, the firm failed to report multiple Medical Device Reports (MDRs) to the FDA within the required 30-day timeframe.