FDA Inspection
Technix S.p.ATechnix S.p.A – FDA Inspection, Sep 19, 2024
Record Details
This FDA Inspection record concerns Technix S.p.A, with an inspection on September 19, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · a8040d95-6e98-4096-9e33-5e260bb48817
Inspection Facts
- Inspection number
- 1249912
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1002.13Failure to submit
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of Technix S.p.A
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2019 | Not classified | Office of Inspections and Investigations | |
| February 3, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Technix S.p.A
- FDA Inspection 1106889 - 2019-09-19
- FDA Inspection 1007067 - 2017-02-03
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