Company
United StatesWyeth BioPharma Division of Wyeth Pharmaceuticals LLC, Andover, MA – FDA Inspections
Inspection records and compliance data for Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC in Andover, MA. 17 FDA inspections on record, 7 Form 483s, last inspected August 06, 2026.
Company Profile
This profile covers Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC based in Andover, MA, United States.
FDA Inspection History
- FDA inspections
- 17
- OAI
- 0
- VAI
- 8
- NAI
- 3
- Unclassified
- 6
- Form 483s
- 7
- Warning letters
- 0
First inspected June 4, 2009. Last inspected August 6, 2026.
Most cited issue areas
- Following/documenting laboratory controls1 inspection
- Lab controls established, including changes1 inspection
FDA inspections (17)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 6, 2026 | Not classified | Biologics | 1331288 |
| April 8, 2026 | Not classified | Human Drugs | 1311392 |
| February 11, 2026 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1304580 |
| October 13, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1223617 |
| September 19, 2023 | VAI | Biologics · Blood and Blood Products | 1218069 |
| May 3, 2019 | Not classified | Human Drugs | 1092777 |
| January 18, 2019 | Not classified | Human Drugs | 1076904 |
| January 17, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1076789 |
| December 15, 2017 | Not classified | Human Drugs | 1040260 |
| October 12, 2017 | Not classified | Human Drugs | 1031394 |
| April 28, 2017 | VAI | Biologics · Vaccines and Allergenic Products | 1020234 |
| September 30, 2016 | VAI | Human Drugs · Drug Quality Assurance | 988784 |
| February 20, 2015 | VAI | Biologics · Vaccines and Allergenic Products | 919172 |
| February 28, 2014 | VAI | Human Drugs · Drug Quality Assurance | 878614 |
| June 20, 2012 | VAI | Biologics, Medical Devices & Rad Health · Blood and Blood Products | 788580 |
| June 11, 2010 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 684531 |
| June 4, 2009 | NAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 590027 |
FDA documents
Related Companies (10)
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Company Information
Name
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
FEI Number
1222181
Address
1 Burtt Rd., Andover, MA 01810, United States
Country
United States
ID: 0de9118f-18ec-45b8-b757-44f97c13c29c