The US FDA released only one device-related close-out letter last month.

Quality systems and Medical Device Reporting violations were noted by US FDA investigators during an on-site inspection of Medtronic’s Northridge, CA, facility. A total of seven device-related warning letters were released by the agency last month.

The US FDA issued three device-related close-out letters in November, with missives going to marketers of power wheelchairs, face masks, and mask decontamination systems.

Invacare, Smiths Medical and CellEra were cited for quality systems and Medical Device Reporting violations in the only device-related warning letters released by the agency last month.

The US FDA released nine close-out letters last month, all of which related to the agency’s crackdown on face masks fraudulently marketed as having FDA clearance.

The warning letter to the Seattle-based company was the product of six-week in-person inspection that stretched from June to July. A total of five device-related missives were released by the US agency last month.

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

The US FDA issued one device-related close-out letter in September.

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.