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.
This Warning Letter is the latest in a series of regulatory issues with ZBH’s legacy Biomet plant. 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. In that response, ZBH reiterated that none of the observations identified specific performance issues with particular products. ZBH also stated disagreement with certain aspects of some of the observations, based on perceived misunderstanding on behalf of the investigators, a lack of context, incomplete information reported by ZBH representatives, etc.
“We take the matters identified in the Warning Letter seriously and are in the process of preparing a written response” within 15 business days, said ZBH leadership in a statement, noting its plans to accept FDA’s proposal for a regulatory meeting.
- This FDA Warning Letter does not preclude ZBH from selling any devices made at the North Campus facility.
- It does prohibit issuance of Certificates to Foreign Governments (FDA certification that the products manufactured there are in compliance with FDA standards) until the deficiencies are corrected.
- It also states that until violations are corrected, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved. The company presently has no such applications before FDA.
An FDA Warning Letter is one of the Agency’s principal means of achieving timely voluntary compliance with the Food, Drug, and Cosmetic Act. John Gagliardi, OMTEC speaker and BONEZONE author, compiled a two-part Anatomy of a Warning Letter; read it here: Part I: A Primer; Part II: Excerpts and Response Strategies.
Sources: Zimmer Biomet, Inc.; ORTHOWORLD Inc.