𝐅𝐨𝐫𝐦𝐞𝐫 𝐅𝐃𝐀 𝐈𝐧𝐯𝐞𝐬𝐭𝐢𝐠𝐚𝐭𝐨𝐫𝐬 𝐑𝐞𝐯𝐞𝐚𝐥𝐞𝐝 𝐖𝐡𝐚𝐭 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐃𝐢𝐝 𝐓𝐡𝐚𝐭 𝐀𝐜𝐭𝐮𝐚𝐥𝐥𝐲 𝐈𝐦𝐩𝐫𝐞𝐬𝐬𝐞𝐝 𝐓𝐡𝐞𝐦 𝐃𝐮𝐫𝐢𝐧𝐠 𝐚𝐧 𝐈𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧

Most inspection readiness programs are built around the same assumption: if your documents are in order, your CAPA system is current, and your staff is trained, you are prepared.

I went back to three of my former FDA Investigator colleagues, combined 40-plus years of field experience between them, and asked each one to describe a facility that actually impressed them during an inspection.

Not a facility that was clean. A facility that made them stop and think: these people have genuinely figured something out.

What they described was consistent across all three conversations. The same behaviors. The same signals. The same moments that told a career Investigator that this quality organization was operating at a level above what the regulations require.

None of the behaviors they described are beyond the reach of a well-managed facility. They do not require exceptional resources or a large quality team.

They require something simpler and considerably harder to manufacture on short notice: a quality culture that operates the same way whether FDA is in the building or not. And the full support of senior management.

The Five Behaviors Are in The Investigator’s Lens

This article covers all five behaviors that career FDA Investigators identified as the markers of a quality organization operating at the highest level — including what each behavior signals to a trained Investigator and exactly what your site should be doing to get there.

It is the third article in the Three Former FDA Investigators series. The most important one yet.

Read the full article here: https://open.substack.com/pub/devaughnedwards/p/d34?r=7sflcx&utm_campaign=post&utm_medium=web&showWelcomeOnShare=true

DeVaughn Edwards is a former FDA Investigator with 14 years of field experience, a pharmaceutical quality executive with 13 years of hands-on compliance leadership, and the founder of FD-AID LLC. He conducts mock FDA inspections and inspection readiness engagements for pharmaceutical manufacturers, CDMOs, and biologics facilities.

Contact: devaughn@fdaid.org | fdaid.org | 732-895-7831