FDA Inspection
Premier Clinical Research LLCPremier Clinical Research LLC – FDA Inspection, Nov 29, 2017
Record Details
This FDA Inspection record concerns Premier Clinical Research LLC, with an inspection on November 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Mark W. Babbitt (Issuing Officer)
View Company Profile
ID · 1f389e9b-81b8-4c91-b79c-9bdd692f8e91
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1032311
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 812.46(a)Sponsor securing investigator compliance
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.43(d)Monitors not qualified
- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
- 21 CFR 812.40Sponsors' general responsibilities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Premier Clinical Research LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2016 | Not classified | Seattle District Office |
Other documents for Premier Clinical Research LLC
- FDA Inspection 987877 - 2016-10-12
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.