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Karl Storz GMBH & Co KG (KSVEM) FDA Inspection Record

FEI 3006453991 · Inspections, Form 483s, warning letters and import refusals

Karl Storz GMBH & Co KG (KSVEM) is an FDA-inspected facility (FEI 3006453991) located in Garching-Hochbruck, DE. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Nov 28, 2012: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Oct 29, 2009
Warning letters
1 listed by FDA for this FEI, latest Feb 23, 2010
Import refusals
10 or more

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Nov 28, 2012Voluntary Action Indicated (VAI)Lack of Written MDR Procedures (21 CFR 803.17)
Oct 29, 2009Official Action Indicated (OAI)Calibration, Inspection, etc. Procedures Lack of or Inadequ (21 CFR 820.72(a))
Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))
Documentation (21 CFR 820.100(b))
Lack of or inadequate process validation (21 CFR 820.75(a))

FDA record score

0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

3 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAINov 28, 201210 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsFeb 23, 201010 years or older, so it adds no points0
Inspection classified OAIOct 29, 200910 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Karl Storz GMBH & Co KG (KSVEM)
Location
Garching-Hochbruck (DE)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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