FDA Inspection
Raritan Pharmaceuticals, Inc.Raritan Pharmaceuticals, Inc. – FDA Inspection, Oct 20, 2016
Record Details
This FDA Inspection record concerns Raritan Pharmaceuticals, Inc., with an inspection on October 20, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
View Company Profile
ID · 779fe977-f104-48a2-84ec-2f8ccae976e3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 995165
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.184(c)Individual inventory record
- 21 CFR 211.204Record information inclusions
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.22(a)Approve or reject components, products
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
Other documents for Raritan Pharmaceuticals, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.