• Regulatory NewsRegulatory News

    FDA Form 483 Cites 14 Observations for Zimmer Biomet

    Just a day before Rep. Tom Price (R-GA) was grilled by senators over his links to the medical device company Zimmer Biomet, the US Food and Drug Administration (FDA) released a Form 483 for the company’s Detroit-based site with 14 observations. The 58-page, heavily-redacted Form 483 follows the site inspection from 12 September 2016 to 22 November 2016. The first observation – on sterilization validation and a “test that has not been adequately validated” – and the seven...
  • Regulatory NewsRegulatory News

    FDA Warns Zimmer Over Quality System Issues at Montreal Plant

    The US Food and Drug Administration (FDA) has issued medical device maker Zimmer Biomet a warning letter over nine quality system issues uncovered at its facility in Montreal. The warning comes as a result of a four-day inspection of the facility that resulted in an FDA Form 483 last January, during which, FDA says its investigators found issues with the company's procedures for implementing corrective and preventative actions, medical device reporting (MDR), purchasing ...