FDA Inspection
Implanet S.A.Implanet S.A. – FDA Inspection, Jul 4, 2025
Record Details
This FDA Inspection record concerns Implanet S.A., with an inspection on July 4, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 9a128340-1f2d-43b3-bdf6-6ec7938fbe02
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1276580
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.50(a)(2)Individual Report of Malfunction
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Other FDA inspections of Implanet S.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 6, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Implanet S.A.
- FDA Inspection 996165 - 2016-10-19
- FDA Inspection 866660 - 2014-02-06
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