Biologische Heilmittel Heel Gmbh, Baden-Baden, Germany – FDA Inspections

Inspection records and compliance data for Biologische Heilmittel Heel Gmbh in Baden-Baden. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 26, 2023.

Company Profile

This profile covers Biologische Heilmittel Heel Gmbh based in Baden-Baden, Germany.

FDA Inspection History

FDA inspections: 5
OAI: 1
VAI: 3
NAI: 1
Form 483s: 1
Warning letters: 0

First inspected July 22, 2010. Last inspected April 26, 2023.

Most cited issue areas

Failing to test for penicillin cross-contamination1 inspection
Following/documenting laboratory controls1 inspection
Investigations of discrepancies, failures1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
April 26, 2023	VAI	Human Drugs · Drug Quality Assurance	1241139
February 1, 2019	VAI	Human Drugs · Drug Quality Assurance	1077837
May 3, 2016	VAI	Human Drugs · Drug Quality Assurance	976690
October 31, 2012	OAI	Human Drugs · Drug Quality Assurance	808745
July 22, 2010	NAI	Human Drugs · Drug Quality Assurance	677561

FDA documents

Form 483s (1)

Form 483s · February 1, 2019

People (2)

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