Company
United StatesFlotec, Inc., Indianapolis, IN – FDA Inspections
Inspection records and compliance data for Flotec, Inc. in Indianapolis, Indiana. 4 FDA inspections on record, 1 Form 483, last inspected August 08, 2019.
Company Profile
This profile covers Flotec, Inc. based in Indianapolis, Indiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 21, 2011. Last inspected August 8, 2019.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Documentation1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 8, 2019 | Not classified | Medical Devices & Rad Health | 1132345 |
| September 1, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 986224 |
| May 9, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 830970 |
| September 21, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 745695 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Flotec, Inc.
FEI Number
1832475
Address
7625 W New York St, Indianapolis, Indiana 46214, United States
Country
United States
ID: fd289515-8fad-4e91-9695-ad4ba724338f