Drug factory · FDA FEI 3000242652

Excella GmbH & Co. KG

Nuernberger Str. 12, Feucht, Germany

Germany: 1

Problems found, fixed voluntarily at FDA's last inspection, Oct 19, 2022.

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 2010: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
CapecitabineMakes it, tests it, packages it and labels it H2-Pharma LLC 61269-470, 61269-475
DeferoxamineMakes the active ingredient and tests it Mitem Pharma 87081-467
LevothyroxineMakes the active ingredient Accord Healthcare Inc. 16729-447, 16729-448, 16729-449 +9
MacitentanMakes it and tests it Actelion Pharmaceuticals US, Inc. 66215-501
NeratinibMakes it, tests it, packages it and labels it Puma Biotechnology, Inc. 70437-240
ParoxetineMakes it, makes the active ingredient and tests it Legacy Pharma USA, Inc. 83107-027
SelexipagMakes it, tests it, packages it and labels it Actelion Pharmaceuticals US, Inc. 66215-602, 66215-604, 66215-606 +8

FDA inspection history

EndedResultProgramProblems noted
Oct 19, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 12, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 17, 2017No problems foundDrug Quality Assurance—
May 29, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
May 17, 2013Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 10, 2012Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 12, 2010No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; label; manufacture; pack.