FDA Investigator Colleen M Aspinwall

Colleen M Aspinwall has inspections in 2 countries as of 14 Nov 2023. Colleen M Aspinwall has collaborated with a combinined 1492 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
110
Last Inspection Date:
14 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Canada
Co-Investigator(s):

Colleen M Aspinwall's Documents

Publish Date Document Type Title
March, 2013 EIR Boca Biolistics, LLC - EIR, 2013-03-20
June, 2013 EIR Samuel N. Lederman, M.D. - EIR, 2013-06-03
June, 2015 FDA 483 Response Innovative Transfusion Medicine, Inc. - Form 483R, 2015-07-07
December, 2015 EIR Innovative Transfusion Medicine, Inc. - EIR, 2015-12-08
March, 2017 FDA 483 Innovative Transfusion Medicine, Inc. - Form 483, 2017-03-16
March, 2011 EIR Diaz, Leslie, M.D. - EIR, 2011-03-08
January, 2018 FDA 483 StemGenex Biologic Laboratories, LLC - Form 483, 2018-01-26
April, 2014 FDA 483 Dr. Raja T. Abboud - Form 483, 2014-04-25
August, 2009 FDA 483 OneBlood, Inc. - Form 483, 2009-08-10
March, 2017 EIR Innovative Transfusion Medicine, Inc. - EIR, 2017-03-16
September, 2009 FDA 483 Good Samaritan Medical Center IRB - Form 483, 2009-09-11
April, 2014 FDA 483 Dr. Norman R. Wasel - Form 483, 2014-04-11
May, 2017 FDA 483 US Stem Cell Clinic, LLC - Form 483, 2017-05-11
March, 2014 FDA 483 Keith A. Aqua, M.D. - Form 483, 2014-03-17
December, 2015 FDA 483 US Stem Cell Clinic, LLC - Form 483, 2015-12-07
March, 2014 EIR Keith A. Aqua, M.D. - EIR, 2014-03-17
February, 2009 FDA 483 Punjwani Sohail S., MD - Form 483, 2009-02-18
February, 2009 FDA 483 Response Punjwani Sohail S., MD - Form 483R, 2009-03-13
March, 2011 FDA 483 Response Diaz, Leslie, M.D. - Form 483R, 2011-03-11
March, 2011 FDA 483 Diaz, Leslie, M.D. - Form 483, 2011-03-08
January, 2010 FDA 483 Sleep Group Solutions, LLC - Form 483, 2010-01-15
September, 2009 FDA 483 Response Good Samaritan Medical Center IRB - Form 483R, 2009-09-11
June, 2015 FDA 483 Innovative Transfusion Medicine, Inc. - Form 483, 2015-06-16
May, 2012 EIR OneBlood, Inc - EIR, 2012-05-11
April, 2014 FDA 483 Dr. Richard K. Elwood - Form 483, 2014-04-25
March, 2016 EIR Creative Testing Solutions - EIR, 2016-03-17
March, 2014 FDA 483 Response Keith A. Aqua, M.D. - Form 483R, 2014-03-24
September, 2015 FDA 483 Miami Stem Cell Treatment Center - Form 483, 2015-09-11
May, 2012 FDA 483 OneBlood, Inc - Form 483, 2012-05-11
July, 2017 FDA 483 Vivex Biologics, Inc. - Form 483, 2017-07-06
April, 2014 FDA 483 Dr. Norman R. Wasel - Form 483, 2014-04-11

Experience Redica System's NEW investigator profiles and dashboards

Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:

  • Total inspections conducted
  • 483 rate
  • OAI rate
  • Warning Letter rate
  • Inspections by Industry, Scope, and Inspection Reason
  • And much more

Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.

FDA Investigator Profile Icon

Talk to sales to access our investigator profiles

Loading...

Investigator Profiles Are Just the Tip of the Iceberg

Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, but also grants you access to:

Inspection Intelligence

  • Pre-Approval Inspection (PAI) trends
  • The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
  • Latest 483s: see what the trends are across all FDA Investigators
  • CFR Heatmap: Citations aggregated by Subpart by Year

Vendor Intelligence

  • Full inspection histories for your vendors down to the specific site level
  • All of the functionality mentioned above but isolated to just your vendors

Regulatory Intelligence

  • Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
  • All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more