FDA Inspection
Criticare Systems, Inc. through Water Tower Capital, LLCCriticare Systems, Inc. through Water Tower Capital, LLC – FDA Inspection, Sep 29, 2010
Record Details
This FDA Inspection record concerns Criticare Systems, Inc. through Water Tower Capital, LLC, with an inspection on September 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 29, 2010
- Product Type
- Devices
View Company Profile
ID · 07b1f1f9-7bec-4ac4-bd7b-d91c5fbf26f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 684561
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Criticare Systems, Inc. through Water Tower Capital, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 31, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Criticare Systems, Inc. through Water Tower Capital, LLC
- FDA Inspection 955859 - 2015-11-20
- FDA Inspection 608649 - 2009-08-31
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