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Audits and Permits

EMINENT facilities are operated under strict compliance with current Good Manufacturing Practice Regulations (21 CFR 211) and all applicable Federal, State, and local regulations. All operations are covered under a body of Standard Operating Procedures (SOPs). Test equipment and facility monitoring devices are calibrated using manufacturer recommended calibration test procedures. Health and Safety issues are well addressed by strict implementation of Facility Safety Plan, Health and Safety Manual, hazardous material spill clean-up plan, and Laboratory Hygiene Plan in compliance with OSHA Laboratory Standard 1910.1450.

EMINENT is registered with the following government agencies and possesses the required permits and licenses to conduct business in performing these Investigational Drug Management Services:

Licenses and Permits

  • FDA Registered Drug Establishment
  • NDC Labeler Code
  • MD State Pharmacy Distributor License
  • MD State Pharmacy License
  • MD State Controlled Dangerous Substance
  • DEA Manufacturing / Distribution / Research / Pharmacy Registration
  • Frederick County Alarm Permit
  • EPA Regulated Waste ID
  • MD State Special Medical Waste ID

AUDIT HISTORY

AUDIT AGENCYDATEDESCRIPTIONREPORT
ANVISA (Brazil)March 24, 2010No critical or major deficiencies were observed. EMINENT is found to operate in accordance with Brazil requirements.
April 14, 2008No critical or major deficiencies were observed. EMINENT is found to operate in accordance with Brazil requirements.
MIT (Russia)July 27, 2018No critical deficiencies were observed. EMINENT is found to operate in accordance with Russian requirements.
MPA (EMEA)November 4, 2013No critical or major deficiencies were observed. EMINENT is found to operate in accordance with EU-GMP.Report
June 18, 2010No critical or major deficiencies were observed. EMINENT is found to operate in accordance with EU-GMP.Report
October 6, 2005A single deficiency that was not critical or major was observed. Apart from the single deficiency, EMINENT is in full compliance with EU-GMP.Report
August 30, 2002No critical or major deficiencies were observed. EMINENT is found to operate in accordance with EU-GMP.Report
PMDASeptember 14, 2006EMINENT is in full compliance with Japanese requirements.Report
US FDAFebruary 6, 2020During 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.
August 14, 2015During 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.Report
January 15, 2010During 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.Report
March 9, 2006During the inspection no objectionable conditions or deficiencies were noted, and no FDA 483 was issued. There were no refusals, and no samples were collected.Report
April 2, 2003A 1-item FDA 483 was issued.Report
August 29, 2002There were no objectionable observations and a FDA 483 was not issued at the close of the inspection. This inspection was classified NAI.Report