FDA Inspection
Diteba IncDiteba Inc – FDA Inspection, Jul 5, 2019
Record Details
This FDA Inspection record concerns Diteba Inc, with an inspection on July 5, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · 417ad912-ceea-4666-8394-0258925e134f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095508
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Diteba Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 4, 2017 | Not classified | Office of Inspections and Investigations | |
| October 29, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Diteba Inc
- FDA Inspection 1112231 - 2019-11-15
- FDA Inspection 1025577 - 2017-08-04
- FDA Inspection 904706 - 2014-10-29
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.