Life Sciences

This Recent FDA Warning Letter Shows You Exactly Why Quality Matters

“Quality, quality, quality.” You hear it all the time from your QA colleagues. There are so many forms to fill out, trainings to complete, procedures to read and follow, and internal audits life-sciences-qualityto produce records for. Sometimes, it’s so overwhelming that we’re tempted to just tune it out.

That is, until we read an FDA Warning Letter like the one issued on November 24 to a Florida-based medical device company. The FDA cites 11 separate violations related to the company’s quality management system (QMS)…and its gaps.

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Where is your organization on its blockchain journey?

AnswerTotal NumberTotal %
Not yet started1300.62
Identifying use cases550.26
Competing a POC90.04
Building a prototype70.03
Doing a pilot50.02
Planning to scale30.01
Total Responses: 209 of 428 (49%)

Violations 9, 10, and 11 are related to failing to follow FDA-mandated reporting procedures for medical devices.

Poll Results for What industry are you in?   
Start Time: April 3, 2018 12:13:22 PM MDT

Total Responses: 222 of 428 (52%)

Results Summary
AnswerTotal NumberTotal %
Automotive70.03
Energy and Utilities140.06
Financial Services and Insurance470.21
Healthcare and Life Sciences600.27
Manufacturing140.06
Retail220.1
Other580.26


While some of the content of the letter might make you chuckle, like the President admitting to false advertising, the fact that they couldn’t produce their device risk assessment in Englishvolume (despite being U.S.-based), or the fact they’re 2.5 years late in reporting product complaints, the truth is that we’re all guilty of quality violations from time to time. Hopefully, not nearly as extreme as this particular company, but nobody’s perfect.

I propose that we use this Letter as a reminder to turn inward, take a look at ourselves, and make sure we’re genuinely doing all that we can to protect the public. Instead of tuning out quality, let’s crank up the volume.

For an assessment or a mock audit of your quality management system (QMS), contact us.

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Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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