FDA Inspection
Gb Implantat TechnologieGb Implantat Technologie – FDA Inspection, Aug 21, 2025
Record Details
This FDA Inspection record concerns Gb Implantat Technologie, with an inspection on August 21, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Gb Implantat Technologie
- Inspection Date
- August 21, 2025
- Product Type
- Medical Devices & Rad Health
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ID · abde9c48-4597-4804-9b1b-dbc39211cffd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1279033
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(g)(2)Periodic equipment inspections
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Other FDA inspections of Gb Implantat Technologie
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 11, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gb Implantat Technologie
- FDA Inspection 1071168 - 2018-08-16
- FDA Inspection 914433 - 2015-02-11
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