Warning Letter Roundup & Recap – Sept. 4, 2018

Zimmer Biomet dinged for quality systems violations in the only device-related warning letter released by US FDA this week.

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Check out Medtech Insight's US FDA Warning Letter Data Tracker here.

This chart lists warning letters released by US FDA the week of Sept. 4, 2018. If an inspection led to...

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More from US FDA Warning Letters

Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 

Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

Warning Letters – June 2025

The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
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Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

More from Compliance

Warning Letters – June 2025

The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.

Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

 

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.

Court Orders US FDA To Return Trial Diversity Action Plan Guidance To Website

 
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HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.