FDA Inspection
Novo Nordisk Pharmaceutical Industries LPNovo Nordisk Pharmaceutical Industries LP – FDA Inspection, Sep 2, 2009
Record Details
This FDA Inspection record concerns Novo Nordisk Pharmaceutical Industries LP, with an inspection on September 2, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 2, 2009
- Product Type
- Drugs
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ID · d4a23119-3ded-419a-a3ad-d626e8acd7e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 618646
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
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Other FDA inspections of Novo Nordisk Pharmaceutical Industries LP
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2025 | Not classified | Atlanta District Office | |
| July 13, 2023 | Not classified | Atlanta District Office | |
| January 12, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 28, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 21, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Novo Nordisk Pharmaceutical Industries LP
- FDA Inspection 1269778 - 2025-06-13
- FDA Inspection 1214533 - 2023-07-13
- FDA Inspection 1041878 - 2018-01-12
- FDA Inspection 1035563 - 2016-01-28
- FDA Inspection 892098 - 2014-08-21
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