Company
United StatesEmerge Diagnostics Inc., Carlsbad, CA – FDA Inspections
Inspection records and compliance data for Emerge Diagnostics Inc. in Carlsbad, California. 2 FDA inspections on record, 1 Form 483, last inspected August 08, 2024.
Company Profile
This profile covers Emerge Diagnostics Inc. based in Carlsbad, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected April 26, 2019. Last inspected August 8, 2024.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 8, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1245806 |
| April 26, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1088818 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Emerge Diagnostics Inc.
FEI Number
3009712031
Address
El Camino Real, Suite 102, Carlsbad, California 92008, United States
Country
United States
ID: ba2abd8f-f460-4e69-b687-3e418042da6b