FDA 483s: One of the Key X Factors is Company Culture

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FDA 483s: One of the Key X Factors is Company Culture

By |2016-07-12T15:53:09-05:00August 12th, 2013|cGMP Quality Assurance and FDA 483s, FDA Inspections, FDAzilla, Form FDA 483|

When all is said and done, avoiding FDA 483s depends most heavily on the organization’s expectations and culture. Attention to quality has to permeate an entire organization from the top down and the bottom up, our panel said.

Employees need to be motivated and incentivized to create products of the highest quality, and managers have to make sure employees aren’t afraid to speak up when they see something go wrong, the experts noted. In the end, all the preparations in the world don’t work if employees don’t care about their jobs.

The best way to gauge your organizational culture is to know what stories are being told. Are they about how hard they’re expected to work? How crazy management is? How awesome the other people on the team are? How attention to detail is celebrated (or shunned)? To change the culture, find a way to change that story.

Sometimes organizational culture is seen as a very “soft” squishy issue. Nonetheless, culture may very well be the most important aspect. It dictates every day behavior and performance, and it always propagates onto itself.  One of my mentors always told me, “As a leader, you’re really only responsible for 2 things: culture and structure. Nail those two things, and you’ll be fine.”

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

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  1. Richard Rysavy August 13, 2013 at 5:24 pm - Reply

    This could not be more spot-on! Having come from an organization that had quality fully integrated in to the culture to my current company that reminds me of the wild west, I can say with absolute confidence that culture is very very important to FDA compliance.

    • Tony Chen August 13, 2013 at 8:34 pm - Reply

      It’s amazing how cultures can differ so significantly! Organizational culture can be such a “squishy” soft topic, but at the end of the day, culture equates to values. And values equates to priorities, and priorities equates to what gets done or not.

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