FDA Inspection
Lonza Walkersville, Inc.Lonza Walkersville, Inc. – FDA Inspection, Jul 3, 2018
Record Details
This FDA Inspection record concerns Lonza Walkersville, Inc., with an inspection on July 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b8e95b40-13a8-4dff-a74a-834c5ac2837c
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1058040
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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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 |
| February 6, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 9, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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