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FDA Inspection
•Rentschler Biopharma Inc.•March 26, 2018

Rentschler Biopharma Inc. – FDA Inspection, Mar 26, 2018

Record Details

This FDA Inspection record concerns Rentschler Biopharma Inc., with an inspection on March 26, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Rentschler Biopharma Inc.
Inspection Date
March 26, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Alice C. Silva (Issuing Officer)
  • Arie Menachem (Issuing Officer)
  • Justin A. Boyd (Investigator)
View Company Profile

ID · b20fd2e8-f6c5-4b7f-b897-73d82dc0902f

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1046134
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

Other FDA inspections of Rentschler Biopharma Inc.

5
DateClassificationOfficeProject area
December 10, 2025Not classifiedNew England District Office
January 17, 2025Not classifiedNew England District Office
March 24, 2023Not classifiedNew England District Office
December 13, 2019VAICenter 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 1259307 - 2025-01-17
  • FDA Inspection 1202865 - 2023-03-24
  • FDA Inspection 1116307 - 2019-12-13
  • FDA Inspection 961189 - 2016-02-23

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