On 5/31/16, Zimmer Biomet (ZBH) received an FDA Warning Letter regarding observed non-conformities at the company’s Zimmer CAS/ORTHOsoft facility in Montreal, Quebec, Canada.
The letter relates to a Form 483 issued following an FDA facility inspection performed in January 2016.
The warning letter does not restrict production or shipment of products from the facility, nor require market withdrawal, nor restrict its ability to seek 510(k) clearances. It does state 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.
Since the inspection, ZBH has provided detailed responses to FDA as to its corrective actions and will continue its work to address issues identified by FDA.
Source: Form 8-K for Zimmer Biomet Inc., SEC.gov
John Gagliardi, OMTEC speaker and BONEZONE author, compiled a two-part Anatomy of a Warning Letter for BONEZONE:
Part I: A Primer
Part II: Excerpts and Response Strategies