FDA Inspection
Mitsubishi Tanabe Pharma Factory Ltd.Mitsubishi Tanabe Pharma Factory Ltd. – FDA Inspection, Jun 10, 2016
Record Details
This FDA Inspection record concerns Mitsubishi Tanabe Pharma Factory Ltd., with an inspection on June 10, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 10, 2016
- Product Type
- Drugs
View Company Profile
ID · d8750c6b-1485-493e-976c-fd342b40bc5c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 974517
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mitsubishi Tanabe Pharma Factory Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mitsubishi Tanabe Pharma Factory Ltd.
- FDA Inspection 751611 - 2011-10-28
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.