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FDA establishment 3014515702, Austin, Texas, United States. Part of Nuclein LLC's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 1
Last inspection ended: Jan 13, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
21 CFR 820.250(b). Sampling plans Sampling plans are not based on valid statistical rationale.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is inadequate.
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
Austin, Texas, United States. Part of