Drug factory · FDA FEI 1222181

Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC

1 Burtt Rd, Andover, MA, United States

United States: 1

Problems found, fixed voluntarily at FDA's last inspection, Apr 8, 2026.

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

5 drug inspections on record since 2009: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AdalimumabMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0025-0319
Adalimumab and Isopropyl AlcoholMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0025-0325, 0025-0328, 0025-0333 +1
BevacizumabMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0315, 0069-0342
Bnt-162b2 Omicron (xfg) MrnaMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-2609, 0069-2631
Bnt162b2 Omicron (lp.8.1)Makes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-2501, 0069-2528
Coagulation Factor Ix Recombinant Human and Isopropyl AlcoholMakes the active ingredient and tests it Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC 58394-633, 58394-634, 58394-635 +2
ElranatamabMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals 0069-2522, 0069-4494, 63539-252
Gemtuzumab OzogamicinMakes the active ingredient and tests it Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-4510
Inotuzumab OzogamicinMakes the active ingredient and tests it Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-0100
MarstacimabMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0775, 0069-1510, 0069-1575 +1
Pneumococcal 20-Valent Conjugate VaccineMakes the active ingredient and tests it Wyeth Pharmaceutical Division of Wyeth Holdings LLC 0005-2000
Recombinant Stabilized Rsv A Prefusion F Antigen and Recombinant Stabilized Rsv B Prefusion F AntigenMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0344, 0069-2465
RituximabMakes the active ingredient Pfizer Laboratories Div Pfizer Inc 0069-0238, 0069-0249
SomatrogonMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0505, 0069-0520
TrastuzumabMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0305, 0069-0308

FDA inspection history

EndedResultProgramProblems noted
Apr 8, 2026Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 13, 2023No problems foundDrug Quality Assurance—
Sep 30, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 28, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 4, 2009No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.