Boston Scientific Corporation — FDA 483 Findings

Corrective and preventive action activities have not been documented, including investigations ofcauses ofnonconformities, the actions needed to correct or prevent recutrence ofnonconforming product and other quality problems, and implementation ofcorrective and preventive actions, OF THIS PAGE > IGE: et Deed AM) PHO: Une ; eM AND a aAree oN TT he = | | Stoneham, MA 02180 —— , A.

Specifically, the training filé fora Distribution Aesaciate/Overstock and Replenishment employeeSBE _ | does not show documentation of training on procedures relating to everyday job duties.

Corrective and preventive actions have not been verified or validated to ensure that the action is effective and does nct niversely affect the finished device.

Specifically, PIR USD 2005-01-01, Part IIIA, Global Medical/Clinical Assessment, did not answerthe question from the Detection section appropriately.

The corrective and preventive action procedures addressing the investigation of the cause of nonconfommities relating to Product, processes, and the qualitysystem were notimplemented.

Employee training is not fully documented.

Required records are not retained for at feast 2 years from the date of release of the device for commercial distribution Specifically, the Emergency FREP Pull Lists, otherwise known as the ZV29 Forms, are discarded.