FDA 483 - Hologic, Inc. - October 14, 2022

Hologic, Inc. in San Diego, CA, a medical device manufacturer, was cited for significant quality system deficiencies during an FDA inspection. Observations included failure to submit a Medical Device Report for a serious injury, inadequate complaint investigations, unapproved design changes, and insufficient design validation and stability testing for their Rapid fFN TLiIQ System. These issues indicate a lack of robust control over critical manufacturing and post-market surveillance processes.