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Merz Pharma GmbH & Co., KGaA, Dessau-Rosslau, Germany – FDA Inspections

Inspection records and compliance data for Merz Pharma GmbH & Co., KGaA in Dessau-Rosslau. 6 FDA inspections on record, 1 Form 483, last inspected June 29, 2022.

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Company Profile

This profile covers Merz Pharma GmbH & Co., KGaA based in Dessau-Rosslau, Germany.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
1
NAI
4
Unclassified
1
Form 483s
1
Warning letters
0

First inspected October 28, 2011. Last inspected June 29, 2022.

FDA inspections (6)

DateResultFDA center(s)Insp. #
June 29, 2022VAIHuman Drugs · Drug Quality Assurance1250812
March 14, 2019Not classifiedHuman Drugs1088213
July 4, 2017NAIHuman Drugs · Drug Quality Assurance1021141
September 15, 2015NAIHuman Drugs · Drug Quality Assurance945417
September 25, 2013NAIHuman Drugs · Drug Quality Assurance853048
October 28, 2011NAIHuman Drugs · Drug Quality Assurance773481
FDA documents

Form 483s (1)

  • Form 483s · November 22, 2019

EIRs (1)

  • EIRs · November 22, 2019
People (3)
Mark C. Saale
Person
Yumi Hiramine
Person
Susan T. Hadman
Person
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Janssen Biotech, Inc.
Regeneron Pharmaceuticals Inc
Immunex Rhode Island Corporation
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Boehringer Ingelheim Biopharmaceuticals (China) Ltd.
Company Information

Name

Merz Pharma GmbH & Co., KGaA

FEI Number

3006896175

Address

Am Pharmapark, Dessau-Rosslau, Germany

Country

Germany

ID: 758203de-10f2-4cff-a0ca-d3b1152277c0

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