FDA Inspection
Kulzer, LLC.Kulzer, LLC. – FDA Inspection, Oct 12, 2018
Record Details
This FDA Inspection record concerns Kulzer, LLC., with an inspection on October 12, 2018, issued by the Detroit District Office, covering medical devices & rad health.
- Company
- Kulzer, LLC.
- Inspection Date
- October 12, 2018
- Product Type
- Medical Devices & Rad Health
- Office
- Detroit District Office
View Company Profile
ID · 9ebaf67d-ba1a-46a2-8e78-f58a0e8a2695
Inspection Facts
- Inspection number
- 1120156
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
Other FDA inspections of Kulzer, LLC.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 20, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 28, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 23, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kulzer, LLC.
- FDA Inspection 1024387 - 2017-07-12
- FDA Inspection 883853 - 2014-06-20
- FDA Inspection 747015 - 2011-09-28
- FDA Inspection 589433 - 2009-06-23
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