Company
United StatesKulzer, LLC., South Bend, IN – FDA Inspections
Inspection records and compliance data for Kulzer, LLC. in South Bend, Indiana. 5 FDA inspections on record, 1 Form 483, last inspected October 12, 2018.
Company Profile
This profile covers Kulzer, LLC. based in South Bend, Indiana, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 23, 2009. Last inspected October 12, 2018.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
- Procedures not adequately established or maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 12, 2018 | Not classified | Medical Devices & Rad Health | 1120156 |
| July 12, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1024387 |
| June 20, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 883853 |
| September 28, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 747015 |
| June 23, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 589433 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Kulzer, LLC.
FEI Number
1821514
Address
4315 S Lafayette Blvd, South Bend, Indiana 46614, United States
Country
United States
ID: 35c53baa-9b43-462a-ab99-f4636a5dec03