Quality’s Regulatory History

Allentown, PA Facility

Food & Drug Administration Inspections (FDA)
- Client Specific PMA – Mar. 2013 (No 483 issued)
- GMP – Jan. 2012 (No 483 issued)
- GMP – Apr. 2011 (No 483 issued)
- GMP – Jul. 2009 (No 483 issued)
- GMP – May 2008 (No 483 issued)
- GMP – Sep. 2006 (No 483 issued)
- GMP – Dec. 2004 (No 483 issued)
- GMP – Jun. 2004 (No 483 issued)
- GMP – Dec. 2003 (No 483 issued)
Drug Enforcement Administration Inspections (DEA)
- Sep. 2011
- Sep. 2010
- Jun. 2008
- May 2007
- Dec. 2006
- Oct. 2006
- Jun. 2005
- Dec. 2004
- Dec. 2003
European Medicines Agency (EMEA)
- GMP – May 2011 (Germany – Site Approved)
- GMP – Jun. 2008 (Germany – Site Approved)
- GMP – Jan. 2006 (France – Site Approved)
ISO 13485:2003 (Medical Device)
- Certified Feb. 2009
ISO 9001:2008 (Drug Packaging)
- Certified Jul. 2009
National Health Surveillance Agency (ANVISA)
- GMP – Jun. 2011 (Brazil – Site Approved)
Pennsylvania Department of Agricultural
- Inspected Apr. 2010

Food & Drug Administration Inspections (FDA)
- GMP – Aug. 2011 (No 483 issued)
- GMP – Sep. 2010 (No 483 issued)
- GMP – Feb. 2009 (No 483 issued)
- GMP – Sep. 2007 (No 483 issued)
- GMP – Jul. 2005 (No 483 issued)
- GMP – Apr. 2004 (No 483 issued)
Drug Enforcement Administration Inspections (DEA)
- Oct. 2011
- Sep. 2010
- Jul. 2010
- Apr. 2006
European Medicines Agency (EMEA)
- GMP – Aug. 2008 (UK – Site Approved)
- GMP – May 2006 (UK – Site Approved)