Walter Eisner – Wed, February 1st, 2017
Zimmer Biomet Holdings, Inc. has a lot of ‘splaining to do to the FDA after an inspection of the company’s Warsaw, Indiana, plant resulted in one the “longest and most serious” 483s ever encountered by a legal expert quoted by Wells Fargo Analyst, Larry Biegelsen.
FDA 483s are “Inspectional Observations,” used by the FDA to document and communicate concerns discovered during inspections. They do not represent a final determination regarding a company’s compliance.
Over the course of three one-week blocks, the agency conducted an inspection at the company and issued a 60-page heavily redacted Form 483 in November.
North Campus Concerns
Prior to the FDA inspection the company completed internal audits of its North Campus in the first half of 2016. According to a January 30, 2017 analyst report by RBC’s Glenn Novarro, these audits identified several compliance-related issues, and a remediation program was established in July 2016. This program identified 7 of the 14 Form-483 observations and 6 of the 15 discussion points prior to the start of the FDA’s inspection.
Biegelsen wrote in mid-December that the 60 heavily redacted pages of the 483 appears to be “severe”, but is unlikely to have a material impact on the business in the near-term because the issues found by the FDA do not impact product approvals and are unlikely to lead to an injunction.