FDA Inspection
Medi-Globe s.r.o.Medi-Globe s.r.o. – FDA Inspection, May 24, 2018
Record Details
This FDA Inspection record concerns Medi-Globe s.r.o., with an inspection on May 24, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · 99649e38-d74b-4051-bc24-359f23214ccc
Inspection Facts
- Inspection number
- 1055265
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.72(b)Calibration procedures - content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medi-Globe s.r.o.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 22, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medi-Globe s.r.o.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.