FDA Investigation of Lead-Testing Facility Uncovers Several Potential Federal Violations

An inspection of a Massachusetts-based Magellan Diagnostics facility has uncovered several potential violations of federal law, according to a statement from Alberto Gutierrez, PhD, director of the US Food and Drug Administration’s (FDA’s) Office of In Vitro Diagnostics and Radiological Health.

Inspectional observations were filed in a report that was issued in Gutierrez’s statement July 13. The report and its observations “do not represent final Agency determination regarding…compliance,” however, according to Gutierrez, the FDA will “carefully review the evidence collected during the inspection to determine if there have been violations of federal and whether further action is warranted.”

Observations include concerns surrounding:

• How testing devices conform to defined user needs and intended uses
• Inadequate risk analysis
• Inadequately established procedures for receiving, reviewing and evaluating complaints by a formally designated unit
• Inadequately established procedures for corrective and preventive action
• Failure to provide a report on the required information regarding device correction and removal actions within 10 days
• Inadequately established procedures for design change
• Failure to establish acceptance criteria prior to performance validation activities
• Failure to submit an MDR report within 30 days of receiving information that reasonable suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur
• Failure to establish procedures to control product that does not conform to specified requirements

According to the report, “under the law, [Magellan Diagnostics] is responsible for conducting internal self-audits to identify and correct any and all violations of the quality system requirements.”

The inspection follows a May 17 FDA announcement that certain Magellan lead tests might provide inaccurate results, and that many patients who have been tested recently using Magellan devices should consult physicians to determine whether a retest is necessary.

Gutierrez emphasized that health care professionals should continue to follow the FDA’s guidelines from May 17, which include directions from the Centers for Disease Control and Prevention (CDC).

“The FDA takes these observations and the risks these tests may have posed to patients very seriously,” Gutierrez wrote. “As we continue our investigation in to the cause of the inaccurate results, the FDA will continue to provide updates on our findings and any changes to our recommendations.”

The CDC recommends that health care professionals retest children younger than 6 as of May 17, if their test was conducted using blood drawn from a vein using any Magellan Diagnostics’ LeadCare System tests and received a result of less than 10 micrograms per deciliter. The CDC also recommends that women who are currently pregnant or nursing and were tested while pregnant or nursing get retested.

According to Magellan Diagnostics’ website, “lead poisoning threatens millions of people, yet is entirely preventable. Our mission is to help identify and protect those at risk.”