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Weleda AG FDA Inspection Record

FEI 1000326682 · Inspections, Form 483s, warning letters and import refusals

Weleda AG is an FDA-inspected facility (FEI 1000326682) located in Schwabisch Gmund, DE. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jul 17, 2024: Voluntary Action Indicated (VAI)
Inspections on record
6 (6 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
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
Jul 17, 2024Voluntary Action Indicated (VAI)No citations listed
Nov 21, 2019Voluntary Action Indicated (VAI)No citations listed
Jun 15, 2018Voluntary Action Indicated (VAI)No citations listed
Jun 10, 2016Voluntary Action Indicated (VAI)No citations listed
Apr 12, 2012Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Component addition checked by 2nd person (21 CFR 211.101(d))
Test methods (21 CFR 211.165(e))
and 3 more
Mar 13, 2012Voluntary Action Indicated (VAI)No citations listed

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
Weleda AG
Location
Schwabisch Gmund (DE)
Source
inspections

Import refusals

FDA data resources

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