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FDA Warning Letter Recap

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

Magellan Lead Test Recall Expanded After First Attempted Fix Found Insufficient

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

Recalls Safety

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

FDA Warning Letter Close-Outs – June 2021

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

Warning Letters FDA

FDA Warning Letter Recap, June 2021: Innova Medical, DeChoker Receive First Post-COVID-19 Inspection-Related Missives

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.

Warning Letters FDA

FDA Warning Letter Recap, May 2021: More COVID-19 Diagnostics Enforcement

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

Warning Letters FDA
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