FDA Inspection
Clinquest Inc.Clinquest Inc. – FDA Inspection, Jun 2, 2015
Record Details
This FDA Inspection record concerns Clinquest Inc., with an inspection on June 2, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Clinquest Inc.
- Inspection Date
- June 2, 2015
- Product Type
- Drugs
View Company Profile
ID · 430604d1-f649-4e8a-827f-d7dffdaa3e5b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 933200
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 314.80(c)(1)(ii)Failure to investigate serious, unexpected events
- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
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.