Drug factory · FDA FEI 2410662
Wyeth Pharmaceutical Division of Wyeth Holdings LLC
401 N Middletown Rd, Pearl River, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 17, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2022: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Desvenlafaxine | Tests it | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1210, 0008-1211, 0008-1222 |
| Gemtuzumab Ozogamicin | Makes it, makes the active ingredient and tests it | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-4510 |
| Inotuzumab Ozogamicin | Makes it, makes the active ingredient, tests it and packages it | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0100 |
| Sirolimus | Makes the active ingredient and tests it | Mylan Pharmaceuticals Inc. | 59762-1001, 59762-1002, 59762-1003 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 17, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Aug 28, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 13, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 17, 2025 inspection
- Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. - Laboratory Test Method Verification 21 CFR 211.194(a)(2)
Verification of the suitability of the testing methods is deficient in that they are not performed under actual conditions of use. - Representative Samples Criteria 21 CFR 211.84(b)
The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria. - Microbiological Contamination Exam 21 CFR 211.84(d)(6)
Each lot of a component that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.
Registered with FDA for: analysis; api manufacture; manufacture; pack.