FDA Investigator Nydia E Colon

Nydia E Colon has conducted inspections on 87 sites in 9 countries as of 10 Jun 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
87
Last Inspection Date:
10 Jun 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Puerto Rico, United States of America, China, Sweden, United Kingdom of Great Britain and Northern Ireland, Germany, Mexico, Italy, Japan
FDA Investigators that have inspected at least one site in common with Nydia E Colon:
Abby E Pelletier, Adaliz Santaliz Cruz, Adam R Cooke, Agnes M Santori, Akbar J Zaidi, Alan A Rivera, Alex J Wild, Althea A Williams, Amanda S Zorn, Andrea George, PhD, Angelica M Hernandez, Annette Melendez, Ariel Cruz Figueroa, Arlene M Badillo, Ashley N Queen, PhD, Barbara T Carmichael, Benjamin K Wolf, Bonnie E Conley, Bonnie E Pierson, Brandon P Thompson, Brentley S Collins, Calvin B Koerner, Carlos Arivera Ramirez, CDR Sean T Creighton, CDR Thomas R Berry, PPh, Cherie T Parker, Cheryl G Scott, Christopher Downey, PhD, Claudette D Brooks, Colleen Thomas, PhD, Daniel J Lahar, Daniel L Aisen, Dayna I Martinez, Dennis Cantellops Paite, Devaughn Edwards, Dianiris C Ayala, Donald C Obenhuber, PhD, Dov H Pluznik, PhD, Dr. Zhihao Qiu (Peter), PhD, Ebony D Sanon, Eliezar Ramos, Emir Galevi, Emma R Schaefer, Enrique Galan, Eric M Padgett, Erika V Butler, Ernest H Blackwood, Frances L Dejesus, Frank J Marciniak, Gamal A Norton, German Rivera, Harry R Bringger, Jr, Hector Jcolon Torres, Herbert M Corbello, Ivis L Negron, Ivonne A Vicente, Jaime E Pares, Jamie P Webb, Jason F Chancey, Jennifer Lalama, Jerri Baker, Jesse A Vazquez, Jorge E Martinez, Jorge L Lajara, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose F Pedro, Jose Perez Soto, Jose R Lopez, Jose Velez, Joseph C Teixeira, Joshua J Silvestri, Juan Rjimenez Garcia, Juarbe, Karl D Hezel, Kimberly Lewandowski Walker, Laiza V Garcia, Laura E Garcia, Leo J Lagrotte, Libia M Lugo, Lindsay R Hatch, Lisa A Warner, Lisa M Lopez, Lizaida E Rodriguez, LT Luis O Rodriguez, LT Rafael Gonzalez, Luis A Carrion, Luis A Martinez Larracuente, Maria Gutierrez Lugo, PhD, Marian E Ramirez, Maricelys Mercado, Marilyn Santiago, Marvin A Marenco, Maxwell Van Tassell, PhD, Medina, Mei Chen Mu, Melanie M Walker, Michael A Charles, Michael G Mayfield, Michael Shanks, MS, Michelle Yclark Stuart, Miguel Gmanzano Maldonado, Milva E Melendez Perales, Minerva Rogers, Monica Cburgos Garcia, Myriam M Sosa, Nicholas Obiri, PhD, Nikolay Spiridonov, Noreen Muñiz, Omotunde O Osunsanmi, Pamela M Thomas, Patricia A Mcilroy, Patricia F Hughes, PhD, Paul E Stein, Paul Z Balcer, Paula A Trost, Penny H Mccarver, Rafael Gonzalez Pizarro, Rafael Nevarez Nieves, Ramesh Potla, PhD, Ramon A Hernandez, Rebecca E Dombrowski, Rebecca Parrilla, Rebecca Rodriguez, Richard K Vogel, Riley C Myers, PhD, Robert Darius, Ronald Ifraimov, Ronald T Weber, Salvatore N Randazzo, Seneca D Toms, Shafiq S Ahadi, Sonia M Monges, Sonya M Edmonds, Stanley B Eugene, BS, BME, Steven C Madzo, Steven Fong, MS, PhD, Suzanne M Healy, Tammara A Stephens, Teresa Jimenez, Terry C Kimball, Thai T Duong, That Q Dang, Thomas J Arista, Timothy Wadkin, PhD, Tony T Yang, Travis E Chapman, Travis S Bradley, Valerie Jgrecek Trinh, Vilmary Negron Rodriguez, Vivian Garcia, Wanda B Coats, Wanda J Torres, Wendy G Tan, PhD, Whitney M White, Yehualashet A Gessesse, Zachary L Stamm, Zhong Li, PhD

Nydia E Colon's Documents

Publish Date Document Type Title
February, 2018 EIR Pall Life Sciences Puerto Rico LLC - EIR, 2018-02-16
April, 2019 FDA 483 D R Burton Healthcare LLC - Form 483, 2019-04-11
August, 2017 FDA 483 Medtronic Puerto Rico Operations Co. - Form 483, 2017-08-29
July, 2017 EIR Amgen Manufacturing Limited LLC - EIR, 2017-07-17
August, 2022 FDA 483 Neocis, Inc. - Form 483, 2022-08-11
February, 2017 FDA 483 Medtronic Puerto Rico Operations Co. - Form 483, 2017-02-17
March, 2017 FDA 483 Medtronic Puerto Rico Operations Co. - Form 483, 2017-03-31
June, 2023 FDA 483 M D I Corporation - Form 483, 2023-06-15
February, 2024 FDA 483 Private Label Productions LLC - Form 483, 2024-02-09
November, 2018 EIR Bard Shannon Limited - EIR, 2018-11-21
September, 2023 FDA 483 Inventex Medical - Form 483, 2023-09-13
November, 2022 FDA 483 DX PRODUCTS LIMITED - Form 483, 2022-11-03
April, 2018 FDA 483 Compumedics USA, Inc - Form 483, 2018-04-13
November, 2022 FDA 483 Boule Medical AB - Form 483, 2022-11-10
October, 2016 FDA 483 Becton Dickinson Caribe LTD - Form 483, 2016-10-07
May, 2023 FDA 483 restor3d Inc. - Form 483, 2023-05-12
November, 2021 FDA 483 Invotec International Inc. - Form 483, 2021-11-04
August, 2019 FDA 483 DeGen Medical Inc. - Form 483, 2019-08-29
August, 2021 FDA 483 Denterprise International, Inc. - Form 483, 2021-08-19
August, 2023 FDA 483 Bard Shannon Limited - Form 483, 2023-08-18
April, 2019 EIR Merck Sharp & Dohme LLC - EIR, 2019-04-05
October, 2021 FDA 483 Medtronic Xomed, Inc. - Form 483, 2021-10-29
May, 2022 FDA 483 Neurotronics LLC. - Form 483, 2022-05-05
March, 2023 FDA 483 Best Image Optical, Inc. - Form 483, 2023-03-09
August, 2022 FDA 483 Neocis Inc. - Form 483, 2022-08-05
May, 2019 FDA 483 Medtronic Puerto Rico Operations Co. - Form 483, 2019-05-31
August, 2021 FDA 483 Command Medical Products, Inc. - Form 483, 2021-08-13
January, 2023 FDA 483 Life Sensing Instruments, Inc. - Form 483, 2023-01-27
November, 2018 FDA 483 Bard Shannon Limited - Form 483, 2018-11-21
September, 2023 FDA 483 Bridge to Life Ltd - Form 483, 2023-09-21
February, 2023 FDA 483 Cutting Edge Spine - Form 483, 2023-02-02
June, 2022 FDA 483 Dentsply Prosthetics - Form 483, 2022-06-16
May, 2024 FDA 483 General Hearing Instruments Inc - Form 483, 2024-05-03
February, 2024 FDA 483 Summit Orthopedic Technologies, Inc. - Form 483, 2024-02-15

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