Magellen Gets Warning Letter On Lead Test Concerns
Executive Summary
The warning letter alleges the company sold modified versions of its blood lead tests without alerting US FDA, and didn’t tell the agency about reported discrepancies in test results. FDA first warned of possible faulty test results in May.
You may also be interested in...
Compliance Corner: When Is An Action Exempt From FDA's Recall Reporting Requirements?
Two longtime industry experts break down the US FDA’s rules around when an action becomes reportable as a recall to the agency. The bottom line: If you’re changing a device’s safety, then you should probably report it.
Warning Letter Roundup & Recap – Oct. 24, 2017
US FDA outlined quality systems and Medical Device Reporting troubles in three device-related warning letters this week, including one addressed to Magellan Diagnostics for ongoing regulatory issues. A fourth letter dinged a firm for failing to have pre-market clearance for its products.
US FDA: Magellan Failed To Ensure Lead Test Accuracy
A US FDA Form-483 inspection report form shows GMP, complaint handling and Medical Device Reporting violations at the Massachusetts facility of Magellan, which is facing serious scrutiny over lead test mishaps.