NARVA Lichtquelle GmbH + Co. KG FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection VAI · Feb 22, 2023
  • Last warning letter 2017
Inspections 3 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Feb 23, 2017
510(k) clearances 0 None on file

NARVA Lichtquelle GmbH + Co. KG has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to NARVA Lichtquelle GmbH + Co. KG, the most recent on Feb 23, 2017.

What these totals cover: FDA records filed under the name "NARVA Lichtquelle GmbH + Co. KG".

Latest inspection
Feb 22, 2023 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

NARVA Lichtquelle GmbH + Co. KG's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

NARVA Lichtquelle GmbH + Co. KG: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202200000
202100000
202000000
201900000
201800000
201710100

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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NARVA Lichtquelle GmbH + Co. KG FDA Warning Letters

1 warning letter on Feb 23, 2017.

IssuedSubjectIssuing officeClose-out letter
Feb 23, 2017 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

3 inspections from Jul 29, 2016 to Feb 22, 2023.

DateSiteProductClassificationFEI
Feb 22, 2023Berlin, GermanyDevicesVoluntary Action Indicated (VAI)3002553648
Sep 28, 2017Berlin, GermanyDevicesVoluntary Action Indicated (VAI)3002553648
Jul 29, 2016Berlin, GermanyDevicesOfficial Action Indicated (OAI)3002553648
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under NARVA Lichtquelle GmbH + Co. KG: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Feb 23, 2017.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002553648Berlin, Germany3Feb 22, 2023

NARVA Lichtquelle GmbH + Co. KG and the FDA: common questions

Has NARVA Lichtquelle GmbH + Co. KG received an FDA warning letter?

Yes. FDA has issued 1 warning letter to NARVA Lichtquelle GmbH + Co. KG. The most recent is dated Feb 23, 2017.

Has NARVA Lichtquelle GmbH + Co. KG received an FDA Form 483?

FDA has not published a Form 483 for "NARVA Lichtquelle GmbH + Co. KG" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect NARVA Lichtquelle GmbH + Co. KG?

The most recent FDA inspection on file ended Feb 22, 2023 at Berlin, Germany and was classified VAI. FDA has 3 inspections of NARVA Lichtquelle GmbH + Co. KG on file, 1 of them classified OAI (official action indicated).

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.