FDA Inspection
Lonza Walkersville, Inc.Lonza Walkersville, Inc. – FDA Inspection, Oct 10, 2008
Record Details
This FDA Inspection record concerns Lonza Walkersville, Inc., with an inspection on October 10, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Lonza Walkersville, Inc.
- Inspection Date
- October 10, 2008
- Product Type
- Biologics
View Company Profile
ID · ecb09338-b326-4f40-9b56-d823e7fc0ed2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 548319
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
10- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.25(b)Training
- 21 CFR 601.12(c)Moderate changes to an approved application
- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.184DHR content
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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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