FDA Inspection
Lonza Walkersville, Inc.Lonza Walkersville, Inc. – FDA Inspection, Feb 6, 2017
Record Details
This FDA Inspection record concerns Lonza Walkersville, Inc., with an inspection on February 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- James M. Simpson (Company Rep)
- Marc S. Neubauer (Issuing Officer)
- Steven P Donald (Issuing Officer)
View Company Profile
ID · 04ee7027-7694-484e-9e51-9b2747e54d14
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1000705
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 807.22(b)(3)Listing not updated
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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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 |
| June 9, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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