FDA Inspection
Novo Nordisk A/S - 25a-BFDA 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
View Company Profile
ID · 03cc787e-f2a0-4966-9bcd-3d7d207ff282
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
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(f)Design verification - documentation
- 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| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2023 | Not classified | Office of Inspections and Investigations | |
| November 4, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 14, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 22, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 18, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.