Drug factory · FDA FEI 3003469991

PCAS Finland Oy

Messukentänkatu 8, Turku, Finland

Finland: 1

Problems found, fixed voluntarily at FDA's last inspection, Jan 10, 2024.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

7 drug inspections on record since 2008: 1 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
BaclofenMakes the active ingredient MAIA Pharmaceuticals, Inc. 70511-123
ElafibranorTests it Ipsen Biopharmaceuticals, Inc. 15054-0080
Gadolinium Cation (3+)Makes the active ingredient and tests it Guerbet LLC 67684-2000, 67684-2001, 67684-3001

FDA inspection history

EndedResultProgramProblems noted
Jan 10, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 13, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 15, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
May 15, 2015No problems foundDrug Quality Assurance—
Feb 8, 2013Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 25, 2010Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 28, 2008Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.