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Medical Device Manufacturing
Sparrow passed the FDA inspection the first time
Sparrow Orthotics · Louisville, KY · 96 employees · Customer since 2022
The problem
Sparrow makes custom orthotic inserts for podiatry clinics. Every lot is patient-specific. Their homegrown system lost lot genealogy 8 times in 2022 — each incident was a reportable quality event. FDA inspection was due in Q1 2023.
What CBHiTech and CloudPeak built
CloudPeak Operate with the lot+serial module fully turned on. Every raw-material lot tied to every finished pair via a mandatory 2-step confirmation at the pour and cure stations. Audit log retention set to 7 years.
Results
- Passed FDA inspection April 2023 — zero 483s
- Lot-genealogy incidents: 8/yr → 0/yr since go-live
- Recall simulation (2024): full cohort identified in 11 minutes
- Audit prep time: 3 weeks → 2 days
"I can find any lot in any box in any clinic from my phone."
Your factory, your numbers.
Want to see what CloudPeak would do in your operation? Book a demo — Caleb calls you back in 30 seconds.
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