FDA Inspection 1181302 — L'Oreal Usa, Inc.

L'Oreal Usa, Inc. — FEI 3003763470

The FDA completed an inspection of L'Oreal Usa, Inc. on September 30, 2022 in Florence, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 30, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Florence, KY (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
360221 CFR 211.160(a)Deviations from laboratory control requirements