Company
United StatesStellar Medical LLC., Fort Myers, FL – FDA Inspections
Inspection records and compliance data for Stellar Medical LLC. in Fort Myers, Florida. 3 FDA inspections on record, last inspected July 11, 2014.
Company Profile
This profile covers Stellar Medical LLC. based in Fort Myers, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 27, 2012. Last inspected July 11, 2014.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 11, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 891591 |
| February 14, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 818922 |
| June 27, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 788024 |
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
Stellar Medical LLC.
FEI Number
3008031067
Address
6385 Presidential Ct Ste 204, Fort Myers, Florida 33919, United States
Country
United States
ID: b75217fb-c577-46f2-a3fe-116f493195dc