FDA 483 - Pink, Inc. dba Hearten - September 30, 2019

An FDA inspection of Pink, Inc. dba Hearten, a medical device manufacturer in Henrico, VA, revealed three significant quality system deficiencies. Observations included inadequate supplier qualification for key contract manufacturing and sterilization services, unvalidated equipment used for sealing and filling convenience kits, and a repeat observation regarding missing approval signatures and dates on Standard Operating Procedures. These issues indicate a lack of control over critical processes and documentation.