FDA Inspection
Kulzer, LLC.Kulzer, LLC. – FDA Inspection, Sep 28, 2011
Record Details
This FDA Inspection record concerns Kulzer, LLC., with an inspection on September 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kulzer, LLC.
- Inspection Date
- September 28, 2011
- Product Type
- Devices
View Company Profile
ID · 3cc587fc-25a6-499a-8cab-92fa71f44122
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 747015
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Kulzer, LLC.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2018 | Not classified | Detroit District Office | |
| 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 |
| June 23, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kulzer, LLC.
- FDA Inspection 1120156 - 2018-10-12
- FDA Inspection 1024387 - 2017-07-12
- FDA Inspection 883853 - 2014-06-20
- FDA Inspection 589433 - 2009-06-23
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