Cranial and facial implant maker OsteoSymbionics LLC has received a warning letter from the Food and Drug Administration for failing to follow industry manufacturing standards.
The FDA listed five violations, most of which seem minor and are related to quality control and record-keeping issues, in a Nov. 30 letter sent to OsteoSymbionics CEO Cynthia Brogan. The violations include failing to establish procedures that ensure design requirements are met and failing to create processes that identify the causes of “nonconforming product.”