FDA Inspection
Medi-Globe s.r.o.Medi-Globe s.r.o. – FDA Inspection, Oct 22, 2010
Record Details
This FDA Inspection record concerns Medi-Globe s.r.o., with an inspection on October 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medi-Globe s.r.o.
- Inspection Date
- October 22, 2010
- Product Type
- Devices
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ID · 2b58a826-0826-43d5-87fd-172a261f9cd2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 699088
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of Medi-Globe s.r.o.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2018 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| February 20, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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