FDA Inspection
Lonza Walkersville, Inc.Lonza Walkersville, Inc. – FDA Inspection, Dec 2, 2011
Record Details
This FDA Inspection record concerns Lonza Walkersville, Inc., with an inspection on December 2, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Lonza Walkersville, Inc.
- Inspection Date
- December 2, 2011
- Product Type
- Biologics
View Company Profile
ID · 9e902282-b907-4760-97b1-4a7ecac223cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 755078
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.70(b)Production and process changes - failure to follow procedure
- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.150(a)Storage procedures to avoid release of unsuitable product
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Lonza Walkersville, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2026 | NAI | Compliance: Devices | |
| November 5, 2021 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 26, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 3, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 6, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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