THYMOORGAN GMBH PHARMAZIE — FDA Facility Profile

FEI 3002320821

THYMOORGAN GMBH PHARMAZIE is an FDA-registered facility (FEI 3002320821) located in Lower Saxony, DE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 9 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 26, 2025: Voluntary Action Indicated (VAI)
Inspections on record
9 (6 VAI, 3 NAI)
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
9

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
Mar 26, 2025Voluntary Action Indicated (VAI)No citations listed
Apr 25, 2023Voluntary Action Indicated (VAI)SOPs not followed / documented (21 CFR 211.100(b))
Environmental Monitoring System (21 CFR 211.42(c)(10)(iv))
Investigations of discrepancies, failures (21 CFR 211.192)
Oct 6, 2022Voluntary Action Indicated (VAI)No citations listed
Jun 20, 2019Voluntary Action Indicated (VAI)No citations listed
Apr 23, 2018No Action Indicated (NAI)No citations listed
Dec 16, 2016No Action Indicated (NAI)No citations listed
Sep 24, 2015No Action Indicated (NAI)No citations listed
May 22, 2014Voluntary Action Indicated (VAI)No citations listed
Feb 9, 2010Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Thymoorgan Pharmazie Gmbh
Location
Lower Saxony (DE)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

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