On Dec. 10, the FDA sent a warning letter to Conformis about quality issues at its operations in Wilmington, Mass.
The FDA inspected the company's medical device operations from Sept. 16 to 20 and then again Nov. 14 and 15. During the investigation, the FDA found manufacturing methods were "not in conformity with the current good manufacturing practice requirements of the Quality System regulations" of the agency.
Conformis responded to the initial inspection's concerns on Oct. 8, outlining long-term corrective action for issues raised, and took further action. But the FDA's Dec. 10 letter stated that the responses did not address its immediate concerns about product sterility. The FDA asked that Conformis provide "objective evidence" that its sterilizers could pass validation for routine operating conditions.