Company

Finland

Lumene Oy, Espoo, Finland – FDA Inspections

Inspection records and compliance data for Lumene Oy in Espoo. 3 FDA inspections on record (1 OAI), last inspected August 26, 2022.

Company Profile

This profile covers Lumene Oy based in Espoo, Finland.

FDA Inspection History

FDA inspections: 3
OAI: 1
VAI: 2
NAI: 0
Form 483s: 0
Warning letters: 0

First inspected November 29, 2013. Last inspected August 26, 2022.

Most cited issue areas

Annual visual exams of drug products1 inspection
Cleaning / Sanitizing / Maintenance1 inspection
Establish reliability of supplier"s C of A1 inspection

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
August 26, 2022	OAI	Human Drugs · Drug Quality Assurance	1178846
June 17, 2016	VAI	Human Drugs · Drug Quality Assurance	981512
November 29, 2013	VAI	Human Drugs · Drug Quality Assurance	856647

FDA documents

Form 483s (1)

Form 483s · August 26, 2022

People (1)

Sean R. Marcsisin

Person

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