Company
United StatesLonza Walkersville, Inc., Walkersville, MD – FDA Inspections
Inspection records and compliance data for Lonza Walkersville, Inc. in Walkersville, Maryland. 11 FDA inspections on record (1 OAI), 3 Form 483s, last inspected March 24, 2026.
Company Profile
This profile covers Lonza Walkersville, Inc. based in Walkersville, Maryland, United States.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 1
- VAI
- 6
- NAI
- 4
- Form 483s
- 3
- Warning letters
- 0
First inspected October 10, 2008. Last inspected March 24, 2026.
Most cited issue areas
- Environmental control Lack of or inadequate procedures3 inspections
- Process control procedures, Lack of or inadequate procedures3 inspections
- Identification of actions needed2 inspections
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 24, 2026 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1307068 |
| November 5, 2021 | VAI | Biologics, Medical Devices & Rad Health · Blood and Blood Products | 1156019 |
| July 26, 2018 | VAI | Biologics · Blood and Blood Products | 1067044 |
| July 3, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1058040 |
| February 6, 2017 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1000705 |
| June 9, 2016 | VAI | Biologics · Blood and Blood Products | 991587 |
| August 13, 2013 | VAI | Biologics · Blood and Blood Products | 849664 |
| December 2, 2011 | VAI | Biologics · Blood and Blood Products | 755078 |
| August 23, 2011 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 737111 |
| December 17, 2009 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 636504 |
| October 10, 2008 | VAI | Biologics · Blood and Blood Products | 548319 |
FDA documents
Form 483s (3)
- Form 483s · November 5, 2021
- Form 483s · February 6, 2017
- Form 483s · June 9, 2016
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Lonza Walkersville, Inc.
FEI Number
1114298
Address
8830 Biggs Ford Rd, Walkersville, Maryland 21793, United States
Country
United States
ID: 5008199b-623e-432c-942c-db06b6333f53