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•United States

Rentschler Biopharma Inc., Milford, MA – FDA Inspections

Inspection records and compliance data for Rentschler Biopharma Inc. in Milford, Massachusetts. 6 FDA inspections on record, 4 Form 483s, last inspected December 10, 2025.

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Company Profile

This profile covers Rentschler Biopharma Inc. based in Milford, Massachusetts, United States.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
3
NAI
0
Unclassified
3
Form 483s
4
Warning letters
0

First inspected February 23, 2016. Last inspected December 10, 2025.

FDA inspections (6)

DateResultFDA center(s)Insp. #
December 10, 2025Not classifiedBiologics1298478
January 17, 2025Not classifiedHuman Drugs1259307
March 24, 2023Not classifiedHuman Drugs1202865
December 13, 2019VAIBiologics · Blood and Blood Products1116307
March 26, 2018VAIBiologics · Blood and Blood Products1046134
February 23, 2016VAIBiologics · Blood and Blood Products961189
FDA documents

Form 483s (6)

  • Form 483s · December 10, 2025
  • Form 483s · January 17, 2025
  • Form 483s · March 22, 2023
  • Form 483s · March 26, 2018
  • Form 483s
  • Form 483s

EIRs (2)

  • EIRs · January 17, 2025
  • EIRs · December 13, 2019
People (6)
Sean R. Marcsisin
Person
Daniel L. Zheng
Person
Arie C. Menachem
Person
Justin A. Boyd
Person
Katherine Niedzwiecki
Person
Michael Henry
Person
Related Companies (10)

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AGC Biologics A/S
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
NOVAVAX CZ
Lonza Biologics, Inc.
Zhejiang Peptites Biotech Co.,Ltd.
Global Calcium Pvt. Limited
Daiichi Sankyo Chemical Pharma Co., Ltd.
Tianjin Asymchem Pharmaceuticals Co., Ltd.
Polpharma Biologics S.A
Company Information

Name

Rentschler Biopharma Inc.

FEI Number

3003282293

Address

27 Maple St, Milford, Massachusetts 01757, United States

Country

United States

ID: 5ef7256a-aef2-44ce-a792-80c28829c138

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