Drug factory · FDA FEI 3005641565

Douglas Manufacturing Limited

Corner Central Park Driveand Te Pai Place, Lincoln Auckland, New Zealand

New Zealand: 1

Problems found, fixed voluntarily at FDA's last inspection, May 30, 2025.

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

6 drug inspections on record since 2011: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AcitretinTests it and packages it Amneal Pharmaceuticals 0115-1750, 0115-1751, 0115-1752 +1
Benzoyl Peroxide and TretinoinMakes it, tests it, packages it and labels it Mayne Pharma Inc. 51862-771
BexaroteneMakes it, tests it, packages it and labels it Upsher-Smith Laboratories, Inc. 0832-0285
ClobazamMakes it, tests it, packages it and labels it Upsher-Smith Laboratories, Inc. 0832-0580, 0832-0581
ExemestaneMakes it, tests it, packages it and labels it Upsher-Smith Laboratories, Inc. 0832-0595
IsotretinoinMakes it Akorn, Upsher-Smith Laboratories, Inc. 61748-301, 61748-302, 61748-303 +8
NintedanibMakes it, tests it, packages it and labels it Exelan Pharmaceuticals, Inc. 76282-786, 76282-787
TretinoinMakes it Glenmark Pharmaceuticals Inc., USA 68462-792

FDA inspection history

EndedResultProgramProblems noted
May 30, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 11, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 1, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 29, 2016No problems foundDrug Quality Assurance—
Jul 4, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
May 31, 2011No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.