FDA Investigator Khin Mang U, MD

Khin Mang U, MD has conducted inspections on 13 sites in 8 countries as of 15 Sep 2017. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
13
Last Inspection Date:
15 Sep 2017
Investigator Role:
FDA Investigation Participant
Redica ID:
100007209
Countries of Inspections:
Italy, Ireland, United Kingdom of Great Britain and Northern Ireland, Hungary, France, Germany, Hong Kong, United States of America
FDA Investigators that have inspected at least one site in common with Khin Mang U, MD:
Cynthia A Harris, MD, RN, Cynthia L Rakestraw, Daniel J Mechenbier, Gerald N Mcgirl, DDS, James R Fleckenstein, Mike M Rashti, Nancy A Bellamy, Regina T Brown, Susan F Laska, MS, Susan Leibenhaut, MD, Tonia L Sawyer, William E Keer

Khin Mang U, MD's Documents

Publish Date Document Type Title
May, 2001 EIR Prof. Gianmarco Corneo, Head, Hematology Sec. - EIR, 2001-06-20
March, 2000 EIR Sandor Timar, M.D. - EIR, 2000-03-03
May, 2010 FDA 483 Quintiles IMS Ireland Limited - Form 483, 2010-05-21
April, 2002 FDA 483 Response Juliana C.N. Chan, M.D. - Form 483R, 2002-04-22
September, 2001 FDA 483 Prof. Michele Tubiana-Hulin - Form 483, 2001-09-14
May, 2010 EIR Quintiles IMS Ireland Limited - EIR, 2010-05-21
November, 2000 FDA 483 Response Gershanovich, Mikhail L - Form 483R, 2001-01-04
September, 2001 EIR Professor Phillipe Cornu, M.D. - EIR, 2001-09-28
September, 2001 FDA 483 Professor Phillipe Cornu, M.D. - Form 483, 2001-09-07
April, 2001 FDA 483 Imperial College of Medicine, Hammersmith Hospital - Form 483, 2001-04-26
April, 2000 FDA 483 Orenstein, Susan R., M.D. - Form 483, 2000-04-12
May, 2001 FDA 483 Response Prof. Gianmarco Corneo, Head, Hematology Sec. - Form 483R, 2001-05-11
September, 2001 EIR Prof. Michele Tubiana-Hulin - EIR, 2001-10-19
November, 2000 FDA 483 Gershanovich, Mikhail L - Form 483, 2000-11-16
September, 2001 FDA 483 Response Prof. Michele Tubiana-Hulin - Form 483R, 2001-10-10
September, 2001 EIR Professor Phillipe Bret, M.D. - EIR, 2001-09-27
March, 2000 FDA 483 Response Sandor Timar, M.D. - Form 483R, 2000-04-19
April, 2001 EIR Prof. John Goldman - Dept. Of Hematology - EIR, 2001-04-26
August, 2000 FDA 483 Dr. James V. Donadio - Form 483, 2000-08-25
May, 2001 FDA 483 Nuovo Ospedale San Gerardo - Univ. of Milano Bicocca - Form 483, 2001-05-03
November, 2000 EIR Gershanovich, Mikhail L - EIR, 2000-11-16
September, 2001 FDA 483 Professor Phillipe Bret, M.D. - Form 483, 2001-09-04
August, 2000 EIR Dr. James V. Donadio - EIR, 2000-08-25
April, 2002 EIR Juliana C.N. Chan, M.D. - EIR, 2002-04-12
April, 2001 FDA 483 Response Prof. John Goldman - Dept. Of Hematology - Form 483R, 2001-04-26
April, 2000 EIR Orenstein, Susan R., M.D. - EIR, 2000-04-12
April, 2002 FDA 483 Juliana C.N. Chan, M.D. - Form 483, 2002-04-12

Experience Redica Systems’ 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