Audits   US FDA Last audited date: 01/15/2010 Audit Date: 01/13/2010 - 01/15/2010 - FDA Final Audit   During the inspection no objectionable conditions or deficiencies were noted, and no FDA 483 was issued. EMINENT facility has been approved for Clinical, Commercial Packaging and Labeling Operations.   Audit Report     Audit Date: 03/07/2006 - 03/09/2006   During the inspection no objectionable conditions or deficiencies were noted, and no FDA 483 was issued. There were no refusals, and no samples were collected.   Audit Report     Audit Date: 04/02/2003   A 1-item FDA 483 was issued.   Audit Report     Audit Date: 08/26/2002 - 08/29/2002   There were no objectionable observations and a FDA 483 was not issued at the close of the inspection. This inspection was classified NAI.   Audit Report     PMDA Last audited date: 09/14/2006 Audit Date: 09/14/2006   EMINENT is in full compliance with Japanese requirements.   Audit Report     MPA (EMEA) Last audited date: 10/06/2005 Audit Date: 10/06/2005   A single deficiency that was not critical or major was observed. Apart from the single deficiency, EMINENT is in full compliance with EU-GMP.   Audit Report     Audit Date: 08/30/2002   No critical or major deficiencies were observed. EMINENT is found to operate in accordance with EU-GMP.   Audit Report

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