FDA EIR - Zimmer Biomet Spine Inc. - March 01, 2018

The FDA conducted a comprehensive inspection of Zimmer Biomet Spine Inc., a medical device manufacturer in Westminster, CO, from February 13 to March 1, 2018. This inspection, carried out under Compliance Program 7382.845 for medical device manufacturers, focused on key quality subsystems including Management Controls, Corrective & Preventive Action (CAPA), Design Controls, and Production & Process Controls. The firm manufactures Class I and II spinal instruments and implants.The inspection identified two primary objectionable conditions, resulting in an FDA Form 483. The most significant issue was the company's failure to submit Medical Device Reports (MDRs) within the mandated 30-day timeframe, a requirement under 21 CFR 803.50(a)(1). Specifically, the company submitted approximately 29 MDRs late for incidents involving serious injury and an additional 51 MDRs late for device malfunctions that could potentially lead to serious injury or death upon recurrence. These delays ranged significantly, with some reports submitted over 200 days past the regulatory deadline.In response to the observations, Zimmer Biomet Spine's General Manager, Mr. George Joe Ross, acknowledged the issues. He stated the firm had already submitted the delayed MDRs and initiated corrective actions, including existing CAPAs to address MDR timeliness. The company also indicated an intent to provide a formal written response within 15 business days, with observations noted as "corrected but not verified" during the inspection close-out.