FDA Inspection
Raritan Pharmaceuticals, Inc.Raritan Pharmaceuticals, Inc. – FDA Inspection, Apr 2, 2025
Record Details
This FDA Inspection record concerns Raritan Pharmaceuticals, Inc., with an inspection on April 2, 2025, issued by the New Jersey District Office, covering human drugs.
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ID · 1a844f99-5473-4890-a8bf-2c8de0080187
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1250227
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.84(b)Representative Samples
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Other FDA inspections of Raritan Pharmaceuticals, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| August 21, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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