WARSAW — Zimmer Biomet has recently received a Form 483 notice from the FDA. The Form 483 is used by the FDA to document and communicate concerns discovered during routine inspections at the north campus location in Warsaw.

The notice was sent to David Kunz, Senior Vice President after inspections were performed from September to November 2016. The full report is 57 pages and heavily redacted of information. It is noted in the forms that it is a “repeat observation” from the FDA inspection performed in 2014.

The concerns that aren’t totally redacted include things like inadequate cleaning processes, not properly documenting chemicals used during cleaning and not monitoring the quality of in-process water.

One observation states, “Your firm’s growing areas and work environments are not consistently designed and constructed in a manner than ensures in-process devices will be protected from personnel and conditions that may adversely impact product quality.”

Zimmer Biomet responded to the form with a statement this afternoon. “Zimmer Biomet takes the FDA matters very seriously and has submitted its written response to the Form 483 observations. The company has developed and is executing a remediation plan to fully address the issues cited by the FDA. The Company will continue to communicate with the FDA regarding the status of the corrective actions and remediation work.”

It’s important to note that a 483 merely consists of observations and does not represent a final agency determination regarding the company’s compliance.

Zimmer Biomet has promised to correct all 14 main observations outlined in the report. You may view the full report here.