Company
United StatesMedifocus, Inc., Columbia, MD – FDA Inspections
Inspection records and compliance data for Medifocus, Inc. in Columbia, Maryland. 3 FDA inspections on record, 1 Form 483, last inspected February 21, 2019.
Company Profile
This profile covers Medifocus, Inc. based in Columbia, Maryland, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 26, 2013. Last inspected February 21, 2019.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Investigation of device failures1 inspection
- Quality Audit/Reaudit - conducted1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 21, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1080032 |
| December 3, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 953902 |
| April 26, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 828779 |
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
Medifocus, Inc.
FEI Number
3009969279
Address
9150 Rumsey Rd Ste A4, Columbia, Maryland 21045-1916, United States
Country
United States
ID: 38d20abc-d043-443a-9e2a-2459b0da9b28