Several additional batches of Magellan’s LeadCare II tests are being recalled as efforts to address the root cause continue.

The US FDA issued three device-related close-out letters in August.

This is the first publicly released inspection-related warning letter sent to a Chinese company since the US FDA stopping sending investigators there in February 2020 because of the COVID-19 pandemic. A total of eight device-related missives were released by the agency in August.

The resolution of a May 2020 warning letter to a breast implant manufacturer accounted for the only device-related close-out latter issued this month.

The US FDA says the 11 companies were selling masks without agency clearance, approval or authorization. A total of 13 device-related missives were released by the FDA in July.

No device-related close-out letters were released by the US FDA last month.

In a sign that inspection-related enforcement is gearing back up, the US FDA sent warning letters to device makers Innova Medical Group and DeChoker LLC that allege quality systems violations. The agency released a total of three device-related missives in June.

The US FDA released two warning letters in May related to the sale of unapproved COVID-19 tests.

Resolved quality systems problems and MDR violations lay behind the four device-related close-out letters posted online by the US FDA in May.

No device-related close-out letters were released by the US FDA last month.

The US FDA released five warning letters in April, all addressed to companies selling COVID-19 tests without agency clearance, approval or authorization.

Surgical sealant firm Ocular Therapeutix received the only device-related close-out letter posted online by the US FDA last month.