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FDA Inspection
•Novo Nordisk A/S - 25a-B•March 19, 2013

FDA Inspection 829270 - Novo Nordisk A/S - 25a-B - March 19, 2013

Record Details

This FDA Inspection record concerns Novo Nordisk A/S - 25a-B, with an inspection on March 19, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company
Novo Nordisk A/S - 25a-B
Inspection Date
March 19, 2013
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · c9477135-df54-42df-8a90-aa5794d6d6ec

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
829270
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

2
  1. 21 CFR 820.30(f)Design verification - documentation
  2. 21 CFR 820.100(a)Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Novo Nordisk A/S - 25a-B

7
DateClassificationOfficeProject area
November 7, 2023Not classifiedOffice of Inspections and Investigations
November 4, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 14, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 22, 2016VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 18, 2015NAICenter for Devices and Radiological HealthCompliance: Devices
View all 7 other inspections on the company page
Other documents for Novo Nordisk A/S - 25a-B
  • FDA Inspection 1223821 - 2023-11-07
  • FDA Inspection 1207487 - 2022-11-04
  • FDA Inspection 1118196 - 2018-06-14
  • FDA Inspection 957571 - 2016-01-22
  • FDA Inspection 933969 - 2015-06-18

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