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FDA establishment 3003763470, Florence, Kentucky, United States. Part of L'Oréal USA's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 5
Official action indicated: 0
Last inspection ended: Apr 1, 2026
Warning letters: 0
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 211.42(c)(2). Rejected Material Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components, drug product containers, closures and labeling before disposition.
21 CFR 211.122(d). Labels and labeling stored separately Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing.
Voluntary Action Indicated (VAI)
Sep 30, 2022
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
21 CFR 211.160(a). Deviations from laboratory control requirements Deviations from written sampling plans and laboratory mechanisms are not recorded and justified.
21 CFR 211.100(a). Changes to Procedures Not Reviewed, Approved Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.
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
Florence, Kentucky, United States. Part of