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.”
Warning letters generally are considered by the FDA to be informal and advisory. The letters typically are a fairly routine part of doing business for medical device firms.
“Of course we would rather not have gotten one, but it’s not uncommon to get these,” Brogan said.
The violations were uncovered in an FDA inspector’s visit to Cleveland-based OsteoSymbionics that began in October.
“The FDA was pretty respectful of a lot of work we’d done,” Brogan said of the record-keeping issues. “It just wasn’t necessarily in the format that they’d expected.”
Brogan was instructed by the FDA to take “prompt action” to correct the violations or face sanctions from the agency that could include financial penalties. The FDA requested that she write back within 15 days detailing the steps the company has taken to address the violations.
Brogan has not yet responded to the letter, but plans to soon, she said.
“Most of the issues have been addressed and corrected, and those that haven’t will be taken care of in the first quarter,” she said.
Founded about four years ago, OsteoSymbionics refers to workers who create its implants as “medical artists.” The workers hand-sculpt implant designs and “painstakingly” fine-tune the implants to fit with a patient’s existing bones, according to the company.
The company has 10 employees. OsteoSymbionics works through distributors to sell its implants to hospitals, Brogan said.