Company
United StatesEight Medical, Inc., Bloomington, IN – FDA Inspections
Inspection records and compliance data for Eight Medical, Inc. in Bloomington, Indiana. 2 FDA inspections on record, 1 Form 483, last inspected May 19, 2017.
Company Profile
This profile covers Eight Medical, Inc. based in Bloomington, Indiana, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 15, 2013. Last inspected May 19, 2017.
Most cited issue areas
- Justification for not reporting1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 19, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1012183 |
| January 15, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 814158 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Eight Medical, Inc.
FEI Number
3009931538
Address
345 S College Ave Apt 103, Bloomington, Indiana 47403, United States
Country
United States
ID: d7a6336a-705a-49aa-8297-4c948a30cdae