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.
Biotronik did not submit medical device reports within the required 30 days of becoming aware that a device had malfunctioned and could contribute to a death or serious injury, the agency said. It noted at least four examples that involved delamination of the Teflon coating during a procedure, and none of the events were reported.
Suppliers were also not property vetted and evaluated, the agency said, noting that the firm’s Select Supplier procedure requires evaluation prior to becoming an approved supplier, but the firm didn’t document evaluations of its component suppliers.
The 483 noted three suppliers that had been used since 2009 but there was no documentation indicating they had been evaluated.
The FDA also cited the firm for not establishing adequate design input procedures. For example, the firm had not adequately defined design input for adhesion/durability and thickness of the hydrophilic coating on the Selectra catheters, the inspector said.
The agency also found fault with the facility’s sampling plans, and said that a statistical rationale was not provided to justify the sampling method for inspections of incoming raw materials.
The firm did not respond to a request for comment by deadline. Read the Form 483 here: www.fdanews.com/08-05-16-Biotronik483.pdf. — Tamra Sami