FDA Inspection
Kat Implants, LLCKat Implants, LLC – FDA Inspection, Apr 7, 2016
Record Details
This FDA Inspection record concerns Kat Implants, LLC, with an inspection on April 7, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kat Implants, LLC
- Inspection Date
- April 7, 2016
- Product Type
- Devices
View Company Profile
ID · 079ea804-e38d-4353-8726-ab1cbc65718e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 965855
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.20(c)Management review dates
Full citation text and observation details available on the Dashboard.
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 16, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 23, 2012 | VAI | 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 874749 - 2014-04-16
- FDA Inspection 784579 - 2012-04-23
- FDA Inspection 681855 - 2010-08-30
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.