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)
CGMP Inspections
- December 2011: Pre-approval Inspection & General Quality Systems Audit (Discovery Ridge)--no 483s
- December 2011: General Quality Systems Audit (ABC Lane)
- April 2010: General Quality Systems Audit--no 483s
- 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
Food & Drug Administration (FDA)
GLP Inspections (General Quality Systems Audits)
- August 2012: no 483s
- 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
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