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Company
•United States

Onyx Pharmaceuticals, Inc., a Subsidiary of Amgen, Inc., South San Francisco, CA – FDA Inspections

Inspection records and compliance data for Onyx Pharmaceuticals, Inc., a Subsidiary of Amgen, Inc. in South San Francisco, California. 3 FDA inspections on record, last inspected February 06, 2015.

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Company Profile

This profile covers Onyx Pharmaceuticals, Inc., a Subsidiary of Amgen, Inc. based in South San Francisco, California, United States.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
2
NAI
1
Form 483s
0
Warning letters
0

First inspected January 20, 2012. Last inspected February 6, 2015.

Most cited issue areas

  • Ensuring compliance with plan and protocol1 inspection
  • General responsibilities of sponsors1 inspection
  • Late submission of 15-day report1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
February 6, 2015NAIHuman Drugs · Drug Quality Assurance914497
May 17, 2013VAIHuman Drugs · Bioresearch Monitoring833837
January 20, 2012VAIHuman Drugs · Bioresearch Monitoring765467
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Dr. Rennan Quijano
Loxo Oncology, Inc.
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Company Information

Name

Onyx Pharmaceuticals, Inc., a Subsidiary of Amgen, Inc.

FEI Number

3009255166

Address

Onyx Pharmaceuticals, Inc., 249 E Grand Ave, South San Francisco, California 94080, United States

Country

United States

ID: 99535d65-fff9-419e-bf57-d11ae158e2e4

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