FDA Inspection
Rontis Hellas S.A.Rontis Hellas S.A. – FDA Inspection, Jul 25, 2024
Record Details
This FDA Inspection record concerns Rontis Hellas S.A., with an inspection on July 25, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4d35b322-a9e0-4a3a-b50f-c3c7fa71bf60
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1245880
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Enforcement
- Warning Letter
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Rontis Hellas S.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Rontis Hellas S.A.
- FDA Inspection 1029354 - 2017-03-30
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