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FDA Inspection
•Novo Nordisk US Bio Production Inc.•August 24, 2018

Novo Nordisk US Bio Production Inc. – FDA Inspection, Aug 24, 2018

Record Details

This FDA Inspection record concerns Novo Nordisk US Bio Production Inc., with an inspection on August 24, 2018, issued by the New England District Office, covering biologics.

Company
Novo Nordisk US Bio Production Inc.
Inspection Date
August 24, 2018
Product Type
Biologics
Office
New England District Office
People
  • Andrey G. Sarafanov (Issuing Officer)
  • Ellen A. Huang (Issuing Officer)
  • Hector A. Carrero (Investigator)
  • Michele L. Forster (Investigator)
  • Obinna R. Echeozo
View Company Profile

ID · ef10d29d-5777-4d7d-94bd-d1f7c5119948

Inspection Facts

Inspection number
1064794
FDA center
Biologics
Outcome
Form 483 issued

Other FDA inspections of Novo Nordisk US Bio Production Inc.

3
DateClassificationOfficeProject area
December 9, 2025Not classifiedNew England District Office
March 5, 2025NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 25, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Novo Nordisk US Bio Production Inc.
  • FDA Inspection 1292060 - 2025-12-09
  • FDA Inspection 1255809 - 2025-03-05
  • FDA Inspection 1214482 - 2023-07-25

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