FDA 483 - Biomet, Inc. - July 15, 2008

Biomet, Inc. in Warsaw, IN, was cited for significant deficiencies in its role as a sponsor of investigational studies. The inspection revealed widespread issues including inadequate monitoring of clinical sites, investigator non-compliance with study protocols and regulations, and failures in obtaining proper IRB approvals for study initiation and plan modifications. These observations highlight a critical lack of oversight in clinical investigations and data integrity.