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Siegfried Hameln GmbH FDA Inspection Record

FEI 3002807877 · Inspections, Form 483s, warning letters and import refusals

Siegfried Hameln GmbH is an FDA-registered facility (FEI 3002807877) located in Hameln Lower Saxony, DE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Aug 29, 2024: Voluntary Action Indicated (VAI)
Inspections on record
7 (1 OAI, 6 VAI)
Last OAI inspection
Jun 14, 2012
Warning letters
1 listed by FDA for this FEI, latest Dec 21, 2012
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
Aug 29, 2024Voluntary Action Indicated (VAI)No citations listed
Sep 1, 2022Voluntary Action Indicated (VAI)No citations listed
Apr 24, 2018Voluntary Action Indicated (VAI)No citations listed
Jul 1, 2016Voluntary Action Indicated (VAI)No citations listed
Jul 25, 2014Voluntary Action Indicated (VAI)Training--operations, GMPs, written procedures (21 CFR 211.25(a))
GMP Training Frequency (21 CFR 211.25(a))
Records reviewed annually (21 CFR 211.180(e))
Jun 14, 2012Official Action Indicated (OAI)No citations listed
Nov 9, 2009Voluntary Action Indicated (VAI)No citations listed

FDA record score

9 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.

8 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIAug 29, 20246 x 0.63.6
Inspection classified VAISep 1, 20226 x 0.63.6
Inspection classified VAIApr 24, 20186 x 0.251.5
Inspection classified VAIJul 1, 201610 years or older, so it adds no points0
Inspection classified VAIJul 25, 201410 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsDec 21, 201210 years or older, so it adds no points0
Inspection classified OAIJun 14, 201210 years or older, so it adds no points0
Inspection classified VAINov 9, 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
Siegfried Hameln GmbH
Location
Hameln Lower Saxony (DE)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE
Source
both

Compliance actions

Import refusals

FDA data resources

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