Quality System Violations Found at Abbott’s St. Jude Medical

A 2/7-17 FDA inspection at Abbott’s St. Jude Medical manufacturing facility in Sylmar, CA, found Quality System Regulation violations in the firm’s manufacturing of the Fortify, Unity, and Assura (including Quadra) implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators and the Merlin@home monitor, according to a 4/12 Warning Letter. Specific violations included: 

•          failing to establish and maintain procedures for implementing corrective and preventive actions;
•          failing to establish and maintain procedures to control product that does not conform to specified requirements;
•          failing to ensure that design verification confirms that the design output meets the design input requirements; and
•          failing to ensure that design validation includes risk analysis, where appropriate.

 The firm’s responses were inadequate or their adequacy could not be determined, the letter says.