It’s one of the top questions asked of FDA consultants: What are the most common issues cited in warning letters and FDA Form 483 observations?

Unfortunately for pharmaceutical and device manufacturers, the FDA prefers to keep the specifics obscured from public knowledge as best as it can. But with personal experience dealing with enforcement actions every day, we’ve decided to share some of our insights to help you prepare accordingly.

Below we’ve highlighted a few important sources of information to use when researching FDA enforcement activities, our own insight into recent trends, and some advice on how to adjust your quality management system.

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Keeping sensitive data and information private and secure is as important to pharmaceutical and device manufacturers as it is difficult.

Companies are increasingly digitizing information about their products and processes, which means compliance with the FDA’s rules on data security has become a top concern.

These protocols are laid out in the FDA’s 21 Code of Federal Regulations (CFR), Part 11. As with most regulations concerning digital information management, Part 11 can seem complicated, especially for those who aren’t well-versed on the systems and procedures it covers. 

To demystify these complex guidelines, we’ve simplified the key takeaways of Part 11 into a quick-and-easy guide. Let’s start with the most basic questions and work our way into the details:

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Whether it’s a list of observations on an FDA 483 or the more immediate threat of a Warning Letter, effective compliance remediation means fully understanding the problems at hand and addressing the root causes of those issues.

But getting to the bottom of a particular problem can be a difficult task. Often, it requires you to string together multiple indicators to reveal an underlying issue. Think of it like a doctor diagnosing an illness by examining each of the symptoms in aggregate.

[Read also:] 5 Common Mistakes to Avoid in Your FDA 483 Response

Many companies take the cheaper, less intensive way out by going through the list of observations and treating the symptoms one-by-one. But easy fixes like this only kick the can down the road. Without resolving the root causes of compliance issues, problems will happen again, likely costing even more to fix.

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