Why we built BlindSpot
BlindSpot did not start in software. It started inside one of the largest solid dosage manufacturing plants in the United States — during a stretch when FDA pressure was real, the inspection cadence was accelerating, and the quality team was working hard without a clear view of where the next focus point would land.
That experience raised a question that stayed with me for years: why are experienced quality organizations — with full QMS platforms, dedicated staff, and seasoned teams — still routinely caught off guard by where FDA focuses next?
Origin
Origin
Years working inside one of the largest solid dosage facilities in the country during a period of significant FDA pressure made one thing clear: compliance systems are built to document. Not to anticipate. The gap between what quality organizations knew and what they needed to know about FDA's next move was wide — and mostly invisible to the teams inside it.
Pattern
Over time, I began looking at FDA behavior differently. Not as isolated events, but as a system with patterns. Districts behaved differently. Citation themes surged and cooled. Findings followed cycles of enforcement emphasis and operational focus. Audits were path dependent — shaped by the facility and by the regulatory environment around it.
Turning point
The distinction between documenting compliance and anticipating regulatory exposure was a gap no one was closing. That insight became the foundation for BlindSpot — a system built not to prove past compliance, but to see where FDA attention is moving before it arrives at your door.
Risk is not just in the site. Risk is in the site inside the current FDA environment.
BlindSpot
Over time, the problem stopped looking like a collection of isolated inspections and started looking like a system with patterns. Some issues were always present in the background. Others surged. Some districts behaved differently. Some findings followed cycles of staffing, training, enforcement emphasis, and operational focus.
Audits were not random. They were path dependent — shaped by both the facility and the regulatory environment around it.
Using public FDA inspection and citation data, BlindSpot detects where enforcement attention is accelerating, stabilizing, or cooling across the issues most relevant to a facility. It was designed to separate chronic compliance noise from the signals that actually matter now.
Approach
Model
Just as insurance prices the driver inside a context — road conditions, vehicle type, claims history — BlindSpot prices risk at the intersection of your facility profile, inspection history, district conditions, and the issues where FDA attention is currently accelerating.
Signal
Not every citation trend matters to your facility. BlindSpot filters external FDA data against your specific CFR exposure profile so what surfaces is relevant to your program — not just recent in the industry.
Reliability
When evidence is sparse, scores dampen rather than force a false signal into the report. Reliability thresholds are visible in every output. You see exactly how confident the scoring is — before you act on it.
Context
Just as insurance does not price the driver alone, BlindSpot does not look at the facility alone. It looks at the interaction between the facility's profile, the systems and process types in place, inspection history, district conditions, and the issues where FDA attention is currently rising.
The name BlindSpot reflects the original problem: not the issues companies know they have, but the exposure they fail to see clearly until FDA sees it first.
From the founder
I know what it feels like to be responsible for what happens when FDA walks through the door.
Not theoretically. From inside a large solid dosage facility during a period of real FDA pressure. The preparation was constant. The stakes were real. And the gap I kept seeing — between what quality organizations knew about their own history and what was sitting in the external FDA record — was the problem no one was closing.
BlindSpot was not built to replace your regulatory judgment. It was built to give you better evidence earlier, so the first conversation with leadership happens before the inspection — not after.
Dave Cortes, PE, PMP — Founder, 483Radar / LeanStorming.com
Start here
If you're responsible for what happens when FDA walks through that door, start with the methodology. See the scoring logic, the reliability framework, and where the limits are — then decide if it fits your program.
Explore next