FDA Inspection
Onyx Pharmaceuticals, Inc., a Subsidiary of Amgen, Inc.Onyx Pharmaceuticals, Inc., a Subsidiary of Amgen, Inc. – FDA Inspection, May 17, 2013
Record Details
This FDA Inspection record concerns Onyx Pharmaceuticals, Inc., a Subsidiary of Amgen, Inc., with an inspection on May 17, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 17, 2013
- Product Type
- Drugs
View Company Profile
ID · 36ebbabe-f6d5-4348-8b91-653621fd01ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 833837
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Onyx Pharmaceuticals, Inc., a Subsidiary of Amgen, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 20, 2012 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Onyx Pharmaceuticals, Inc., a Subsidiary of Amgen, Inc.
- FDA Inspection 914497 - 2015-02-06
- FDA Inspection 765467 - 2012-01-20
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.