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](https://redica.com/document-store/images/InspectorProfile.png)
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