FDA Inspection
Criticare Systems, Inc. through Water Tower Capital, LLCCriticare Systems, Inc. through Water Tower Capital, LLC – FDA Inspection, Aug 31, 2009
Record Details
This FDA Inspection record concerns Criticare Systems, Inc. through Water Tower Capital, LLC, with an inspection on August 31, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 31, 2009
- Product Type
- Devices
View Company Profile
ID · d4e907ed-970e-47ce-8540-b6afa44281be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 608649
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
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 |
| September 29, 2010 | 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 684561 - 2010-09-29
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.