Company
United StatesRemel, Inc, Lenexa, KS – FDA Inspections
Inspection records and compliance data for Remel, Inc in Lenexa, Kansas. 7 FDA inspections on record, last inspected March 03, 2023.
Company Profile
This profile covers Remel, Inc based in Lenexa, Kansas, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 3
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected November 18, 2009. Last inspected March 3, 2023.
Most cited issue areas
- Contamination control, Lack of or inadequate procedures1 inspection
- Documentation1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 3, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1199839 |
| October 23, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 953769 |
| July 3, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 885210 |
| June 25, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 836927 |
| March 7, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 823206 |
| March 18, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 658081 |
| November 18, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 631902 |
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
Remel, Inc
FEI Number
1924669
Address
12076 Santa Fe Trail Dr, Lenexa, Kansas 66215, United States
Country
United States
ID: f75612ef-610e-4ee4-980b-47569a492300