FDA Inspection
Kat Implants, LLCKat Implants, LLC – FDA Inspection, Apr 23, 2012
Record Details
This FDA Inspection record concerns Kat Implants, LLC, with an inspection on April 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kat Implants, LLC
- Inspection Date
- April 23, 2012
- Product Type
- Devices
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ID · ae121dd6-4b7a-4357-aefd-032a8d036980
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 784579
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Kat Implants, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2026 | Not classified | New England District Office | |
| September 16, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 7, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 16, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 30, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kat Implants, LLC
- FDA Inspection 1310876 - 2026-03-18
- FDA Inspection 1179705 - 2022-09-16
- FDA Inspection 965855 - 2016-04-07
- FDA Inspection 874749 - 2014-04-16
- FDA Inspection 681855 - 2010-08-30
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