FDA Investigator Freddy Ortiz Colon

Freddy Ortiz Colon has conducted inspections on 14 sites in 5 countries as of 14 Mar 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
14
Last Inspection Date:
14 Mar 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
India, Finland, Switzerland, France, Belgium
FDA Investigators that have inspected at least one site in common with Freddy Ortiz Colon:
Ademola O Daramola, Akbar J Zaidi, Anastasia M Shields, Ann Marie Montemurro, Ann Marie Schofield, Anna Lazar, Atul J Agrawal, Azza Talaat, Bryan A Galvez, Burnell M Henry, Carolina D Vasquez, CDR Jeremy L Wally, PhD, Christian D Lynch (CDL), Claire M Minden, Cynthia J Lee, MS, Cynthia Jim, CSO, Daniel J Roberts, Darren S Brown, David A Oluwo, Dipesh K Shah, Doan T Nguyen, PharmD, Douglas C Kovacs, Dr. Barbara D Paul, PhD, Eileen A Liu, Emmanuel Jramos Maldonado, Eric M Mueller, PharmD, Farhana Khan, Felix Maldonado, Gam S Zamil, Gwyn G Dickinson, Jacqueline Mdiaz Albertini, Jawaid Hamid, Jay T Wong, Jeffery A Hangartner, Jennifer L Gustavus, Jogy George, Jose Acruz Gonzalez, José E Meléndez, June P Page, Justin A Boyd, Kent C Faul, Kham Phommachanh, Kim Lthomas Cruse, Kristen D Evans, Larry K Hampton, Lisa B Orr, Lisa Shin, Marie B Buen Bigornia, Marvin D Jones, Matthew B Casale, Michael L Chasey, Michael R Goga, Michele Perry Williams, Miguel A Martinez Perez, Mihaly S Ligmond, Mizanne E Lewis, Mra B Kamberem, Nebil A Oumer, Nicholas L Paulin, Nicole E Knowlton, Omotunde O Osunsanmi, Pankaj H Amin, Paula A Trost, Peter E Baker, Prabhu P Raju, Randa Melhem, PhD, Rose Ashley, Saleem A Akhtar, Sangeeta M Khurana, PhD, Sanket N Patel, Scott T Ballard, Sherry G Bous, Simone E Pitts, Stephen D Eich, Steven M Weinman, Taichun Qin, PhD, Tamil Arasu, PhD, Terri L Dodds, Thomas J Arista, Timothy T Kapsala, Tomika L Bivens, Toyin B Oladimeji, Unnee Ranjan, Veronica Fuentes, MS, Virgilio F Pacio, CSO, Walden H Lee, Yasamin Ameri, Yonggang Wang, PhD, Yumi J Hiramine, Yvins Dezan

Freddy Ortiz Colon's Documents

Publish Date Document Type Title
June, 2013 EIR Baxalta Belgium Manufacturing SA - EIR, 2013-06-18
June, 2013 FDA 483 Baxalta Belgium Manufacturing SA - Form 483, 2013-06-18
March, 2015 FDA 483 Fresenius Kabi Oncology Limited - Form 483, 2015-03-03
November, 2019 FDA 483 EUGIA PHARMA SPECIALITIES LIMITED - Form 483, 2019-11-13
April, 2023 FDA 483 Similasan AG - Form 483, 2023-04-04

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