Quality System Failures Found at Biotronik’s Berlin Facility

The FDA found process validation, medical device reporting and other quality system failures at Biotronik’s Berlin facility during a recent inspection.

The six-item 483 said that the firm didn’t validate its hydrophilic coating process used to manufacture the Selectra catheter lead introducer system used to facilitate lead implantation in the heart.

“Your firm’s validation process is inadequate in that it failed to demonstrate consistency of the coating process because it only included one device, and did not include the testing of coating integrity, coating adhesion or thickness, and failed to conduct the effects of upper and lower limits of parameters such as cycle time,” the 483 said. — Tamra Sami