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FSSB Chirurgische Nadeln Gmbh FDA Inspection Record

FEI 3001082387 · Inspections, Form 483s, warning letters and import refusals

FSSB Chirurgische Nadeln Gmbh is an FDA-inspected facility (FEI 3001082387) located in Jestetten, DE. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Apr 23, 2015: Voluntary Action Indicated (VAI)
Inspections on record
3 (1 OAI, 2 VAI)
Last OAI inspection
Sep 20, 2012
Warning letters
1 listed by FDA for this FEI, latest Jan 29, 2013
Import refusals
4

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
Apr 23, 2015Voluntary Action Indicated (VAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)
Sep 20, 2012Official Action Indicated (OAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Nonconforming product control (21 CFR 820.90(a))
Documentation of software validation (21 CFR 820.70(i))
Sampling plans (21 CFR 820.250(b))
Oct 22, 2009Voluntary Action Indicated (VAI)Design verification - Lack of or inadequate procedures (21 CFR 820.30(f))
Nonconforming product control (21 CFR 820.90(a))
Calibration standard traceability (21 CFR 820.72(b)(1))
Verify, validate change {see also 820.100(a)} (21 CFR 820.100(a)(4))

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.

4 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIApr 23, 201510 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsJan 29, 201310 years or older, so it adds no points0
Inspection classified OAISep 20, 201210 years or older, so it adds no points0
Inspection classified VAIOct 22, 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
FSSB Chirurgische Nadeln Gmbh
Location
Jestetten (DE)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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