FDA Inspection
RanD S.P.A.RanD S.P.A. – FDA Inspection, Sep 14, 2018
Record Details
This FDA Inspection record concerns RanD S.P.A., with an inspection on September 14, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · b07b2137-a88e-4201-ad9f-577191fb1d3c
Inspection Facts
- Inspection number
- 1065572
- 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 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of RanD S.P.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 16, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 10, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for RanD S.P.A.
- FDA Inspection 1199247 - 2023-02-16
- FDA Inspection 650552 - 2010-02-10
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