FDA Inspection
Raritan Pharmaceuticals, Inc.Raritan Pharmaceuticals, Inc. – FDA Inspection, Aug 21, 2012
Record Details
This FDA Inspection record concerns Raritan Pharmaceuticals, Inc., with an inspection on August 21, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 21, 2012
- Product Type
- Drugs
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ID · 03248a1a-d694-4d0b-b656-3e883d512301
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 798953
- 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)(2)Statement of methods and data
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Raritan Pharmaceuticals, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2025 | OAI | New Jersey District Office | Drug Quality Assurance |
| January 8, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 20, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 14, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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