FDA Inspection
Raritan Pharmaceuticals, Inc.Raritan Pharmaceuticals, Inc. – FDA Inspection, Jan 8, 2018
Record Details
This FDA Inspection record concerns Raritan Pharmaceuticals, Inc., with an inspection on January 8, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f275a0be-8cda-446f-9c15-5566f69959dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037112
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
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Other FDA inspections of Raritan Pharmaceuticals, Inc.
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| April 2, 2025 | OAI | New Jersey District Office | Drug Quality Assurance |
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| 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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