Regulatory Record

"We are in a stage of development where timing is very critical. The tremendous effort displayed by ABC staff over the past week (and weekend) has allowed our company to accelerate our decision-making process. It is this level of dedication that will keep us coming back over and over."

Tom Wilson, Senior Director of QA/QC
Orexigen Therapeutics, Inc.
(with permission)

Regulatory Record

When it comes to regulatory compliance, few contract laboratories compare with ABC Laboratories' track record for 483-free inspections.

Food & Drug Administration (FDA)
GMP Inspections

July 2008: Pre-Approval and General Quality Systems Audit--no 483s
March 2005: General Quality Systems Audit--no 483s
June 2004: Pre-Approval and General Quality Systems Audit--no 483s

GLP Inspections (General Quality Systems Audits)

November 2009: no 483s

July 2006: no 483s

June 2004: no 483s

October 2002: no 483s

Environmental Protection Agency (EPA)
GLP Inspections & Data Audits

No observed adverse findings over last 20 years (8 inspections, 1989-2009)

Drug Enforcement Agency (DEA)

Controlled Substance Registration Certificate

7200 E ABC Lane renewed 5/2009

Discovery Ridge granted 6/2008

Nuclear Regulatory Commission (NRC)

Materials License renewed 12/2008

AAALAC Accreditation

Continuation of full accreditation last confirmed 11/2008