FDA 483 - Lafayette Work Center, Inc. - August 26, 2019

Lafayette Industries North, Inc., a drug repackager and relabeler in Berkley, MO, was cited for three observations during an FDA inspection. Deficiencies included inadequate procedures and documentation for handling drug product complaints, lack of documented training for core staff and management, and failure to maintain written records for major equipment cleaning, maintenance, and use. These issues indicate significant non-compliance with current good manufacturing practice regulations.