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FDA establishment 3010351679, Brentwood, Tennessee, United States. Part of BlephEx, LLC's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 1
Last inspection ended: Nov 19, 2025
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed, maintained and implemented.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Brentwood, Tennessee, United States. Part of