Biomet, Inc. – FDA 483, Nov 22, 2016

This FDA Form 483 document details numerous observations regarding inadequate validation, quality system deficiencies, and control issues at a medical device manufacturing facility.

**Key Observations:**

* **Sterilization Validation:** The metals family sterilized by (b)(4) has not been adequately validated to achieve a Sterility Assurance Level (SAL) of (b)(4). Assessments for adopting devices into this family are not routinely documented. The bioburden monitoring and dose audit program for the metals family is inadequate, using simulated product that does not represent approximately (b)(4) item numbers. The initial validation (Validation #79, approved 3/14/2003) and all requalifications (2004-2015) lack objective evidence of achieving the specified SAL. Justification for simulated product use and placement of sterility samples/IPCDs in difficult-to-sterilize locations was not documented. Load configurations changed between validation and requalification without justification. * **Packaging System Validation:** The Package System Validation Corporate Biomet Procedure (CP1516 Rev. 1) references conformance to EN 868-5:2009, but (b)(4). * **Equipment and System Validation:** Performance Qualifications are not consistently performed with actual or simulated product. Installation Qualifications (IQs) lack predetermined acceptance criteria and objective evidence of meeting input requirements. Validations for (b)(4) Water Systems in