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Reimbursement / Regulatory

Zimmer Biomet (ZBH) received an FDA Warning Letter on August 24 related to observed non-conformities with current good manufacturing practice requirements at ZBH’s North Campus facility in Warsaw, Indiana. The quality violations cited were found during a 2016 inspection, documented by FDA in a Form 483. A re-inspection in April resulted in another Form 483, to which ZBH responded to in June. This FDA Warning Letter does not preclude ZBH from selling any devices made at the North Campus facility. (Zimmer Biomet, 8/27/10)