Company
Czech RepublicMedi-Globe s.r.o., Hranice 1, Czech Republic – FDA Inspections
Inspection records and compliance data for Medi-Globe s.r.o. in Hranice 1. 3 FDA inspections on record, 1 Form 483, last inspected May 24, 2018.
Company Profile
This profile covers Medi-Globe s.r.o. based in Hranice 1, Czech Republic.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 22, 2010. Last inspected May 24, 2018.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Calibration procedures - content1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 24, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1055265 |
| February 20, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 917429 |
| October 22, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 699088 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Medi-Globe s.r.o.
FEI Number
3004129994
Address
Olomoucka 306, Hranice 1, Czech Republic
Country
Czech Republic
ID: 933c5ac6-eb42-4ad3-8e19-3b9109a25d1f