FDA Inspection
Wassenburg Medical, Inc.Wassenburg Medical, Inc. – FDA Inspection, Apr 24, 2015
Record Details
This FDA Inspection record concerns Wassenburg Medical, Inc., with an inspection on April 24, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Wassenburg Medical, Inc.
- Inspection Date
- April 24, 2015
- Product Type
- Devices
View Company Profile
ID · 7f31bee0-27e8-4705-af6a-ef175e05a922
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 923746
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Wassenburg Medical, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 28, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 19, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 8, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 26, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Wassenburg Medical, Inc.
- FDA Inspection 1077765 - 2018-10-19
- FDA Inspection 1010565 - 2017-04-28
- FDA Inspection 904108 - 2014-11-19
- FDA Inspection 807881 - 2012-11-08
- FDA Inspection 765157 - 2012-01-26
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