FDA Inspection
NARVA Lichtquelle GmbH + Co. KGNARVA Lichtquelle GmbH + Co. KG – FDA Inspection, Sep 28, 2017
Record Details
This FDA Inspection record concerns NARVA Lichtquelle GmbH + Co. KG, with an inspection on September 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Cynthia L. Aycock (Issuing Officer)
View Company Profile
ID · 54d31587-cfe9-48f5-9713-f03fb72536b4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027652
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.80(e)Documentation
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
Full citation text and observation details available on the Dashboard.
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 |
| July 29, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for NARVA Lichtquelle GmbH + Co. KG
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.