FDA Inspection
NARVA Lichtquelle GmbH + Co. KGNARVA Lichtquelle GmbH + Co. KG – FDA Inspection, Jul 29, 2016
Record Details
This FDA Inspection record concerns NARVA Lichtquelle GmbH + Co. KG, with an inspection on July 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 29, 2016
- Product Type
- Devices
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ID · 7539e8b4-c208-453a-b022-d9350de79416
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 981931
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.70(f)Buildings
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.86Acceptance status
- 21 CFR 820.72(b)Remedial action
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Other FDA inspections of NARVA Lichtquelle GmbH + Co. KG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 28, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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