FDA Inspection
G21 SrlG21 Srl – FDA Inspection, May 25, 2017
Record Details
This FDA Inspection record concerns G21 Srl, with an inspection on May 25, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d37cb158-0327-4fc9-80fb-a914889dc1b2
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1012795
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of G21 Srl
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2025 | Not classified | Office of Inspections and Investigations | |
| December 1, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for G21 Srl
- FDA Inspection 1273678 - 2025-05-21
- FDA Inspection 1194285 - 2022-12-01
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