FDA Inspection
Wassenburg Medical, Inc.Wassenburg Medical, Inc. – FDA Inspection, Jan 26, 2012
Record Details
This FDA Inspection record concerns Wassenburg Medical, Inc., with an inspection on January 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Wassenburg Medical, Inc.
- Inspection Date
- January 26, 2012
- Product Type
- Devices
View Company Profile
ID · 91cae8d4-7768-45e4-a5af-c26fd60a3a1c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 765157
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 820.30(g)Design validation - documentation
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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 |
| April 24, 2015 | OAI | 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 |
Other documents for Wassenburg Medical, Inc.
- FDA Inspection 1077765 - 2018-10-19
- FDA Inspection 1010565 - 2017-04-28
- FDA Inspection 923746 - 2015-04-24
- FDA Inspection 904108 - 2014-11-19
- FDA Inspection 807881 - 2012-11-08
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