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FDA Warning Letter Recap

Warning Letter Close-Outs – December 2021

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

Warning Letters FDA

FDA Warning Letter Recap, December 2021: Medtronic Feels The Heat

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.

Warning Letters FDA

Warning Letter Close-Outs – November 2021

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.

Warning Letters FDA

FDA Warning Letter Recap, November 2021: 3 Device Makers Cited After On-Site Inspections

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.

Warning Letters FDA

Warning Letter Close-Outs – October 2021

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.

Warning Letters FDA

FDA Warning Letter Recap, October 2021: Maker Of Blood Collection Device Cited For Quality System Violations

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.

Warning Letters FDA

FDA Warning Letter Recap, September 2021

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

Warning Letters FDA

Warning Letter Close-Outs – September 2021

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

Warning Letters FDA

Warning Letter Close-Outs – August 2021

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

Warning Letters Compliance

FDA Warning Letter Recap, August 2021: On-Site Inspection Of Chinese Device Maker Uncovers Quality Systems Troubles

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.

Warning Letters FDA

Warning Letter Close-Outs – July 2021

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.

Warning Letters FDA

FDA Warning Letter Recap, July 2021: Device Center Brings Hammer Down On Face Mask Vendors

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.

Warning Letters FDA
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