FDA establishment 3039142471, Carmel, Indiana, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
FY2018 to FY2027 to date; 0 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
Inspections citing each reference
| Ended | Product and area | Citations | Classification |
|---|---|---|---|
| Jan 13, 2026 | Devices · Compliance: Devices | 2 cited references
| Voluntary Action Indicated (VAI) |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters
Carmel, Indiana, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.