FDA Inspection 1178846 - Lumene Oy - August 26, 2022

FDA Inspection 1178846 for Lumene Oy on August 26, 2022. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 1178846 for Lumene Oy on August 26, 2022. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 211.113(a)

21 CFR 211.160(a)

21 CFR 211.170(b)

21 CFR 211.182

21 CFR 211.192

21 CFR 211.67(a)

21 CFR 211.84(d)(2)

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Record Information

Company

Lumene Oy

Inspection Date

August 26, 2022

Product Type

Drugs

Office

Center for Drug Evaluation and Research

ID: f7a13e1e-9b56-4743-b0e3-1bbaf6a9c734

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