FDA Inspection
RIJ Pharmaceutical LLCRIJ Pharmaceutical LLC – FDA Inspection, Oct 30, 2015
Record Details
This FDA Inspection record concerns RIJ Pharmaceutical LLC, with an inspection on October 30, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- RIJ Pharmaceutical LLC
- Inspection Date
- October 30, 2015
- Product Type
- Drugs
View Company Profile
ID · df6e67b7-1155-49ec-a06f-b695ad1e1969
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 948378
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of RIJ Pharmaceutical LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2018 | OAI | 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 1048639 - 2018-04-13
- FDA Inspection 723513 - 2011-05-02
- FDA Inspection 669871 - 2010-05-27
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.