UPDATE : Friday, September 22, 2017
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FDA’s Magellan inspection hints at possibility of legal violations
  • By Marian Chu
  • Approval 2017.07.14 15:14
  • comments 0

The U.S. Food and Drug Administration Thursday released findings of their inspection into Magellan Diagnostics’ inaccurate lead test while pursuing further investigations to “determine if there have been violations of federal law.”

The FDA warned the public last month regarding Magellan Diagnostics’ LeadCare test systems that provided inaccurate blood results. The federal agency stated their preliminary warning aimed to “warn (impacted) laboratories, health care professionals, and people.”

Magellan Diagnostics is a private medical device company that develops blood lead tests.

The agency revealed their final investigation findings in Form-483, issued at the end of an inspection to notify a company of conditions that violate the Food Drug and Cosmetic Act.

The report outlined that the company’s product did perform as marketed or designed, failed to identify potential risks to patients, and did not adequately review customer complaints without procedures for corrective action.

The FDA stated that they are “carefully reviewing” collected evidence to determine whether further action is warranted.

“As we continue our investigation into the cause of the inaccurate results, the FDA will continue to provide updates on our findings and any changes to our recommendations,” said Alberto Gutierrez at FDA’s Center for Devices and Radiological Health.

yjc@docdocdoc.co.kr

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