FDA Inspection
NARVA Lichtquellen GmbH + Co. KGNARVA Lichtquellen GmbH + Co. KG – FDA Inspection, Sep 24, 2026
Record Details
This FDA Inspection record concerns NARVA Lichtquellen GmbH + Co. KG, with an inspection on September 24, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- September 24, 2026
- Product Type
- Medical Devices & Rad Health
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ID · e309252f-4386-4acc-a896-b47a0c2afcf6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1338884
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
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Other FDA inspections of NARVA Lichtquellen GmbH + Co. KG
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 22, 2023 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| May 24, 2019 | Not classified | Office of Inspections and Investigations | |
| May 12, 2017 | Not classified | Office of Inspections and Investigations | Radiation Control and Health Safety Act |
Other documents for NARVA Lichtquellen GmbH + Co. KG
- FDA Inspection 1209579 - 2023-06-22
- FDA Inspection 1111714 - 2019-05-24
- FDA Inspection 1017475 - 2017-05-12
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