FDA Inspection
RIJ Pharmaceutical LLCRIJ Pharmaceutical LLC – FDA Inspection, Apr 13, 2018
Record Details
This FDA Inspection record concerns RIJ Pharmaceutical LLC, with an inspection on April 13, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e035e91d-b45e-45ee-9649-c023fb95169b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1048639
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
6- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
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Other FDA inspections of RIJ Pharmaceutical LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 2, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 27, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for RIJ Pharmaceutical LLC
- FDA Inspection 948378 - 2015-10-30
- FDA Inspection 723513 - 2011-05-02
- FDA Inspection 669871 - 2010-05-27
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