Craniofacial implant maker OsteoSymbionics has received an FDA warning letter for, among other things, failing maintain procedures to ensure certain design requirements were met. The inspection took place between Oct. 13 and Nov. 3 of this year.
In its letter, the FDA says certain design controls were inadequate during the development of the design of the Cranial Plate Implant, which has been distributed since 2008. As MedCity News notes, most of the five violations appeared to be and related to quality control and record-keeping issues.
"Of course we would rather not have gotten one, but it's not uncommon to get these," CEO Cynthia Brogan explains, as quoted by MedCity News. "The FDA was pretty respectful of a lot of work we'd done," Brogan added. "It just wasn't necessarily in the format that they'd expected."
OsteoSymbionics refers to workers who create its implants as "medical artists" who hand-sculpt implant designs and "painstakingly" fine-tune the implants to fit with a patient's existing bones, according to the company.