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FDA Releases Inspection Report for Lead Test Manufacturer

July 17, 2017

The FDA released a Form 483 with nine observations issued to Magellan Diagnostics following an inspection of its North Billerica, Mass., facility from May 10 through June 29. The inspection was prompted by reports of inaccurate readings by the firm’s LeadCare blood lead tests.

Agency inspectors found numerous problems, including inadequate risk analysis, improperly evaluated complaints and failure to submit MDR documentation. The agency said it is reviewing the documentation collected to determine any further actions needed and whether the facility violated federal laws.

The FDA issued a safety warning about the lead test systems on May 17, and Magellan recalled two of the four devices affected by the notice, the LeadCare Plus and LeadCare Ultra blood lead tests.

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