FDA Inspection
Aurora Medbiochem CompanyAurora Medbiochem Company – FDA Inspection, Sep 4, 2014
Record Details
This FDA Inspection record concerns Aurora Medbiochem Company, with an inspection on September 4, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aurora Medbiochem Company
- Inspection Date
- September 4, 2014
- Product Type
- Drugs
View Company Profile
ID · ad7e5077-2112-4412-af3b-6d3991c62ea5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 893964
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.188(b)(9)Description of containers and closures
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(5)In-process and laboratory control results
- 21 CFR 211.188(b)(13)Examinations for correct labeling
- 21 CFR 211.188(b)(6)Inspection of packaging and labeling area
- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.165(a)Testing and release for distribution
Showing 10 of 14 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Aurora Medbiochem Company
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 14, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aurora Medbiochem Company
- FDA Inspection 945408 - 2015-10-14
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.