FDA Inspection
Mondeal Medical Systems GmbhMondeal Medical Systems Gmbh – FDA Inspection, Sep 19, 2019
Record Details
This FDA Inspection record concerns Mondeal Medical Systems Gmbh, with an inspection on September 19, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · d6b2e1a3-87bb-4bdc-8c12-c9e5884704cb
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1102228
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Mondeal Medical Systems Gmbh
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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