FDA Inspection
Novo Nordisk A/SNovo Nordisk A/S – FDA Inspection, Sep 3, 2013
Record Details
This FDA Inspection record concerns Novo Nordisk A/S, with an inspection on September 3, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Novo Nordisk A/S
- Inspection Date
- September 3, 2013
- Product Type
- Drugs
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ID · d4ee5da4-3a33-41c2-bf98-f33b8e2cca57
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 846713
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of Novo Nordisk A/S
8| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 5, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 18, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 8, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 8, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Novo Nordisk A/S
- FDA Inspection 1245306 - 2023-03-29
- FDA Inspection 1165895 - 2019-12-05
- FDA Inspection 1057438 - 2018-05-18
- FDA Inspection 1007260 - 2017-02-08
- FDA Inspection 964462 - 2016-04-08
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