FDA WARNING_LETTER - Zimmer Manufacturing B.V. - June 22, 2012

This FDA Warning Letter, dated [Date of Letter], was issued to Zimmer Inc. following an inspection of their manufacturing facility in Ponce, Puerto Rico, from June 5-22, 2012. The inspection revealed that their Trilogy / Acetabular Cup and Trilogy Spike Cup products, Class II implantable hip replacements, are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

A primary violation cited was the failure to validate processes that cannot be fully verified by subsequent inspection and test, as required by 21 C.F.R. § 820.75(a). Specifically, the manufacturing processes for Trilogy Acetabular Cup products lacked a mechanism to demonstrate adherence to pre-determined specifications for pore size and porosity, critical for biological fixation. Despite developing specifications in March 2009, no release testing was implemented by the June 2012 inspection. Additionally, a specific Trilogy Acetabular Cup model incorporating (b)(4) in its design had an unvalidated (b)(4) process affecting bond integrity, yet the product continued to be released for 10 months after this finding.

The firm's corrective and preventive action (CAPA) system was found inadequate (