Firm Cited for Inadequate Complaint Procedures

Biomedicare failed to adequately employ appropriate complaint-handling procedures by not completing and, in some cases, not initiating complaint investigations for its dental implants, according to an FDA warning letter.

“We remain very concerned about your complaint and [medical device record] handling procedures,” the agency wrote in the June 19 letter, posted on the FDA’s website earlier this month. “Some complaints have no documentation of activity for five or six months after receipt,” the agency said.

The firm was also cited for not validating its sterilization process or its clean room, which is used for packaging its products.