FDA Inspection
Medicalplastic S.R.L.Medicalplastic S.R.L. – FDA Inspection, Mar 19, 2026
Record Details
This FDA Inspection record concerns Medicalplastic S.R.L., with an inspection on March 19, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 428f9f70-29aa-4438-bc1a-dd6873663dd9
Inspection Facts
- Inspection number
- 1308072
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 8.2.4Internal audit program not planned
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of Medicalplastic S.R.L.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2018 | NAI | Compliance: Devices | |
| June 30, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medicalplastic S.R.L.
- FDA Inspection 1080180 - 2018-12-17
- FDA Inspection 736781 - 2011-06-30
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