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BIOLOGISCHE HEILMITTEL HEEL GMBH FDA Inspection Record

FEI 3002806504 · Inspections, Form 483s, warning letters and import refusals

BIOLOGISCHE HEILMITTEL HEEL GMBH is an FDA-registered facility (FEI 3002806504) located in DEU D-76532, DE. Registered operations: MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 26, 2023: Voluntary Action Indicated (VAI)
Inspections on record
5 (1 OAI, 3 VAI, 1 NAI)
Last OAI inspection
Oct 31, 2012
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
Apr 26, 2023Voluntary Action Indicated (VAI)No citations listed
Feb 1, 2019Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Following/documenting laboratory controls (21 CFR 211.160(a))
Lab controls established, including changes (21 CFR 211.160(a))
Testing and release for distribution (21 CFR 211.165(a))
and 3 more
May 3, 2016Voluntary Action Indicated (VAI)No citations listed
Oct 31, 2012Official Action Indicated (OAI)No citations listed
Jul 22, 2010No Action Indicated (NAI)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
Biologische Heilmittel Heel Gmbh
Location
DEU D-76532 (DE)
Registration Expires
Dec 31, 2026
Operations
MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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