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

 
• By Shawn M. Schmitt

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.

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Checkout MedtechInsight'sUSFDAWarningLetterDataTracker here.

This chart lists device-related warning letters released by the US Food and Drug Administration in October 2021. If an inspection led to the warning letter, the location of the inspected...

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More from US FDA Warning Letters

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

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Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
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Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

Dexcom Wins FDA Nod For 15-Day G7 CGM, Closing Gap With Abbott’s 14-Day FreeStyle Libre

 
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AI-Based Screening Tool For Musculoskeletal Issues Gets US FDA Warning Letter

 
• By Elizabeth Orr

Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.

More from Compliance

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
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Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.