If you’ve received an FDA Form 483 following a site investigation, it’s important to avoid making a bad situation worse by submitting a poor response.

Too often, companies don’t take these responses as seriously as they should, demonstrating to regulators it either doesn’t understand the changes it needs to make or is unwilling to invest the resources to do so.

[Read also:] 5 Items to Stock in Your FDA Inspection War Room

Here are a few common mistakes to avoid when crafting your response to an FDA 483:


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The 510(k) isn’t like many other regulatory submissions. With so many devices on the market, one submission can look very different from another depending on its type, history, and the risk factors involved.

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The FDA’s newly updated guidance agenda for 2016 provides a glimpse into the areas the Agency plans to focus on over the next few months. With 102 total guidances currently on the list, this year will see a modest increase in new regulatory initiatives compared to last year’s total of 92.

A look at the list reveals three areas of interest that stick out among the rest:

  1. Pharmaceutical quality manufacturing standards
  2. Pharmaceutical quality/CMC
  3. Generics

While the full list of the proposed guidances is available here, we’ve summarized the three key points of focus along with some additional insights into these topics below.

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