FDA Inspection
Kat Implants, LLCKat Implants, LLC – FDA Inspection, Aug 30, 2010
Record Details
This FDA Inspection record concerns Kat Implants, LLC, with an inspection on August 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kat Implants, LLC
- Inspection Date
- August 30, 2010
- Product Type
- Devices
View Company Profile
ID · f2267deb-a480-44bd-8790-e0442c326967
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 681855
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, 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 |
| April 23, 2012 | 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 784579 - 2012-04-23
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