FDA Inspection
Noven Pharmaceuticals, Inc.Noven Pharmaceuticals, Inc. – FDA Inspection, Feb 14, 2011
Record Details
This FDA Inspection record concerns Noven Pharmaceuticals, Inc., with an inspection on February 14, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Noven Pharmaceuticals, Inc.
- Inspection Date
- February 14, 2011
- Product Type
- Drugs
View Company Profile
ID · 4c8eddb7-c4b3-4201-b41b-22ad8a67e58b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 711251
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Noven Pharmaceuticals, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 2, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Noven Pharmaceuticals, Inc.
- FDA Inspection 828778 - 2013-04-24
- FDA Inspection 792909 - 2012-08-02
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