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FDA Inspection
•Rentschler Biopharma Inc.•January 17, 2025

Rentschler Biopharma Inc. – FDA Inspection, Jan 17, 2025

Record Details

This FDA Inspection record concerns Rentschler Biopharma Inc., with an inspection on January 17, 2025, issued by the New England District Office, covering human drugs.

Company
Rentschler Biopharma Inc.
Inspection Date
January 17, 2025
Product Type
Human Drugs
Office
New England District Office
People
  • Daniel L. Zheng (FDA Associated Person)
  • Divek R. Jumani (Company Rep)
  • Sean R. Marcsisin (FDA Associated Person)
  • Vivek Jumani (Issuing Officer)
View Company Profile

ID · fdfa31e1-e0c6-4326-a766-0c0d2116da07

Inspection Facts

Inspection number
1259307
FDA center
Human Drugs
Outcome
Form 483 issued, view the record

Other FDA inspections of Rentschler Biopharma Inc.

5
DateClassificationOfficeProject area
December 10, 2025Not classifiedNew England District Office
March 24, 2023Not classifiedNew England District Office
December 13, 2019VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 26, 2018VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 23, 2016VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Rentschler Biopharma Inc.
  • FDA Inspection 1298478 - 2025-12-10
  • FDA Inspection 1202865 - 2023-03-24
  • FDA Inspection 1116307 - 2019-12-13
  • FDA Inspection 1046134 - 2018-03-26
  • FDA Inspection 961189 - 2016-02-23

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