FDA Investigator Christina L Bigham

Christina L Bigham has inspections in 6 countries as of 15 Nov 2023. Christina L Bigham has collaborated with a combinined 4537 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
109
Last Inspection Date:
15 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Malaysia, United Kingdom of Great Britain and Northern Ireland, Germany, Taiwan
Co-Investigator(s):
A Williams, Aaron L Dunbar, Alan Escalona, Albert L Nguyen, Alec M O'neal, Allison C Hunter, Allison E Sincek, Allison M Mcgloin, Allison M Scheck, Amanda Dinaro, Amber M Capello Jones, Amy L Mccarthy, Amy L Mcintyre, Amy S Graf, Ana M Placencia, Andrew A Hoopes, Andrew I Carr, Andrew J Lang, Andrew M Kupper, Anna M Brannen, April L Brown, April L Young, Arie R Dyk, Arthur Z Liang, Bailey A Uetrecht, Bemjamin J Dastoli, Benjamin E Bowen, Benjamin J Dastoli, Benjamin J Smith, Benjamin P Stewart, Benjamin W Anderson, Bili Jom Johnson, Billi Jom Johnson, Bonnie E Conley, Bradley A Servais, Brenda C Hamilton, Brigitte K Hofmann, Brigitte Kh Strelnik, Brittany M Kershaw, Bryan J Love, Byungja E Marciante, Carlos Hruiz Nunez, Cassandra L Winters, Catherine D Djordjevic, CDR Sean T Creighton, Charles M Spyr, Christine E Kelley, Christine M Parmentier, Christopher A Demitrius, Christopher T Middendorf, Clifford F Long, Cody D Rickman, Craig P Seaborn, Craig T Rybus, Cynthia T Cain, D Yvette Barnett, Daisy E Ramos, Daniel L Aisen, Danielle M Maddox, Darren S Morgan, David J Gasparovich, David J Leray, David P Moorhead, David S Jackson, Dell S Moller, Demetria L Lueneburg, Denise L Burosh, Dennis R Butcher, Dennis R Hock, Diane R Mcdaniel, Dina K West, Dmitry Gazarian, Donna D Gallien, MPH, Donna F Campbell, Dyvette Arline, Edward E Lockwood (EEL), Edward R Kay, Elizabeth Ll Edwards, Elizabeth P Kinsella, Eric C Fox, Eric M Padgett, Eric S Pittman, Evan M Kupper, Farhana Khan, Felipe Rde Almeida, Francis A Guidry, Genevieve E Ghand, Geoffrey K Kilili, George G Calafactor, Georgia A Layloff, Gerald D Bromley, Jr, Gina M Brackett, Green, Gregory A Berg, Gregory W Smith, Gregson A Joseph, Harperd, Heather A Mccauley, Holly J Rapier, Holly J Wilson, Hugh M Mcclure, II, Jaclyn N Munsch, James A Beaulieu, James A Lane, James D Planchon, James G Marsh, James Norman, Jamie P Webb, Janet B Abt, Jason Channels, Jason D Abel, Jason D Werne, Javonica F Penn, Jeffrey A Sincek, Jennifer L Gustavus, Jennifer L Jager, Jennifer L Sheehan, Jennifer M Heitz, Jennifer S Ness, Jessica A Stephens, Jessica L Johnson, Jill R Loeliger, Jill R Raezer, Jocelyn M Muggli, Joey C West, John A Iwen, John D Jaworski, John E Marszalek, John E Russell, John L Stevens, John P Roetting, II, Jon P Antoniou, Joseph D Gong, Joseph M Edwin, Joseph R Strelnik, Joseph X Kaufman, Joshua P Wireman, Joshua S Hunt, Julie N Vosilus, Kara D Dobbin, Karen M Cruz Arenas, Karen M Rodriguez, Katelyn Astaub Zamperini, Kathryn Carroll, Katie L Korchinski, Keith J Mason, Kellie L Westerbuhr, Kelly D Sheppard, Kenneth E Felkley, Kimberly A Joseph, Kinh Q Mac, Kirk W Gaston, Klein, Konsuela Y Glass, Kyle J Mccracken, Laiza V Garcia, Laureen M Geniusz, Lauren N Howard, LCDR Matthew J Morrison, Leslie R Clark, Lindsey M Schwierjohann, Lisa R Hilliar, Lori A Carr, Lori A Lahmann, Lori S Lawless, Luckner Jean Marie, Lydia S Chan, Maney P Sturgil, Maney P Sturgill, Marcia A Worley, Marianne Allen, Maribeth G Grattan, Maribeth G Niesen, Marie A Fadden, Marissa S Henning, Marissa S Steinhagen, Mark E Parmon, Mary A Millner, Mary K Concannon, Mary L Schuckmann, Matt D Suedkamp, Matthew A Walburger, Matthew B Casale, Matthew H Pitts, Matthew R Mcnew, Melissa D Kalik, Melissa I Michurski, Michael A Charles, Michael D Thatcher, Michael E Campbell, Michael K Larson, Michael P Sheehan, Mildred J Tures, Monica J Wilkins, Msdap Gonzlezk, Myra K Casey, Nadeem I Chaudhry, Nicholas L Paulin, Nicholas T Domer, Nicole C Victoria, PhD, Nina Ni, Paola E Lathrop, Philip J Boston, Philip S Woodward, Phillip M Pontikos, Pifer, Ralph Jerndal, Ralph W Jemdal, Raquel L Coleman, Rebecca Clark, Rhonda L Mecl, Richard D Coleman, Richard J Bashay, Richard W Berning, Robbie J Alleman, Robert Rodriguez, Robert Sharpnack, Rosanna M Goodrich, Rosanna M Vaccaro, Rosannam Voeearo, Ross J Grigsby, Roy C Stephens, Rterry Bolen, Ryan J Benedict, Scott A Golladay, Seema S Singh, Shafiq S Ahadi, Sharon L Matson, State Agency, Stephen D Eich, Steven D Kehoe, Steven J Rush, Susan M Atcher, Susan M Matthias, Susan M Taylor, Suyang Qin, Sydney S Choi, Talmane J Fisher, Teresa K Kastner, Thomas A Peter, Thomas B Smith, Thomas C Woods, Thomas J Prigge, Tiki J Dixon, Timothy G Philips, Tony T Yang, Toyin B Oladimeji, Tracey L Harris, Tracy A Solseng, Troy A Huffman, Tyler R Courtney, Ulysses D Singleton, Wanda B Coats, Wen Ning Chan (Sally), Whitney M White, William C Corley, William D Tingley, William F Lagud, Jr, William R Brubaker, Yehualashet A Gessesse, Yoon K Oh

Christina L Bigham's Documents

Publish Date Document Type Title
October, 2021 FDA 483 Spartronics Watertown LLC - Form 483, 2021-10-28
February, 2018 FDA 483 Response MHC Medical Products LLC - Form 483R, 2018-02-26
March, 2022 FDA 483 Taurus Engineering and Manufacturing, Inc. - Form 483, 2022-03-10
September, 2021 FDA 483 Exercore, LLC - Form 483, 2021-09-02
November, 2018 FDA 483 Hi HealthInnovations - Form 483, 2018-11-30
March, 2018 FDA 483 AtriCure, Inc. - Form 483, 2018-03-09
December, 2022 FDA 483 Access Point Technologies - Form 483, 2022-12-20
November, 2016 FDA 483 Teva Women's Health LLC - Form 483, 2016-11-10
June, 2019 FDA 483 Premier Biotech, Inc. - Form 483, 2019-06-17
March, 2017 FDA 483 Reliance Medical Products Inc - Form 483, 2017-03-07
March, 2017 FDA 483 Full Range Rehab LLC - Form 483, 2017-03-15
November, 2018 FDA 483 Starkey Labs Inc - Form 483, 2018-11-13
May, 2022 FDA 483 rms Company - Form 483, 2022-05-18
February, 2017 FDA 483 EQM Research Inc - Form 483, 2017-02-15
February, 2020 FDA 483 Primus Corporation dba Trinity Biotech - Form 483, 2020-02-06
August, 2017 FDA 483 Philips Medical Systems (Cleveland) Inc - Form 483, 2017-08-18
June, 2017 FDA 483 Invacare Corporation - Form 483, 2017-06-16
February, 2019 EIR InTheSmart Co., Ltd. - EIR, 2019-02-12
December, 2022 FDA 483 Crest Electronics Inc - Form 483, 2022-12-28
February, 2022 FDA 483 Spineology, Inc. - Form 483, 2022-02-15
July, 2022 FDA 483 LISI MEDICAL Remmele, Inc - Form 483, 2022-07-12
December, 2021 FDA 483 Southwest Technologies Inc - Form 483, 2021-12-08
April, 2021 FDA 483 Smiths Medical ASD Inc. - Form 483, 2021-04-30
February, 2018 EIR MHC Medical Products LLC - EIR, 2018-02-02
September, 2018 EIR Surface Dynamics LLC dba Lincotek Medical - EIR, 2018-09-26
September, 2017 FDA 483 Surgical Appliance Industries Inc - Form 483, 2017-09-22
January, 2021 FDA 483 Lifecore Biomedical, LLC - Form 483, 2021-01-21
November, 2015 FDA 483 3M Company - Form 483, 2015-11-06
January, 2018 FDA 483 Endoprime Inc - Form 483, 2018-01-04
July, 2019 FDA 483 Iowa Adaptive Technologies Inc. - Form 483, 2019-07-11
December, 2015 EIR Dole Fresh Vegetables, Inc. - EIR, 2015-12-01
June, 2016 FDA 483 Cintas Corporation - Form 483, 2016-06-24
June, 2016 EIR Cintas Corporation - EIR, 2016-06-24
June, 2019 FDA 483 Response Premier Biotech, Inc. - Form 483R, 2019-06-17
April, 2018 FDA 483 Biomet, Inc. - Form 483, 2018-04-24
January, 2021 EIR Lifecore Biomedical, LLC - EIR, 2021-01-21
March, 2023 FDA 483 Smiths Medical ASD Inc. - Form 483, 2023-03-03
June, 2022 EIR Scapa Tapes North America, LLC - EIR, 2022-06-17
March, 2018 EIR AtriCure, Inc. - EIR, 2018-03-09
August, 2019 FDA 483 Biomerieux Inc - Form 483, 2019-08-20
April, 2019 FDA 483 Response Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.) - Form 483R, 2019-05-15
August, 2018 FDA 483 Gentherm Medical, LLC - Form 483, 2018-08-30
April, 2017 FDA 483 Dynavision Global Holdings LLC - Form 483, 2017-04-26
January, 2017 FDA 483 Gentherm Medical, LLC - Form 483, 2017-01-18
November, 2022 FDA 483 Medtronic Neuromodulation - Form 483, 2022-11-03
June, 2022 FDA 483 Scapa Tapes North America, LLC - Form 483, 2022-06-17
April, 2018 FDA 483 Response Biomet, Inc. - Form 483R, 2018-05-15
August, 2021 FDA 483 Covidien, LLC - Form 483, 2021-08-03
November, 2015 EIR 3M Company - EIR, 2015-11-06
February, 2018 FDA 483 MHC Medical Products LLC - Form 483, 2018-02-02
August, 2017 EIR Philips Medical Systems (Cleveland) Inc - EIR, 2017-08-18
July, 2018 FDA 483 Integra LifeSciences Corporation - Form 483, 2018-07-02
October, 2021 FDA 483 Collaborative Care Diagnostics, LLC dba BioMedix - Form 483, 2021-10-18
April, 2019 FDA 483 Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.) - Form 483, 2019-04-24
September, 2018 FDA 483 Surface Dynamics LLC dba Lincotek Medical - Form 483, 2018-09-26
July, 2019 FDA 483 Titronics Research & Development Co. - Form 483, 2019-07-09
August, 2023 FDA 483 Biomerics LLC - Form 483, 2023-08-25
February, 2019 FDA 483 Bionet Co., Ltd. - Form 483, 2019-02-21
December, 2023 FDA 483 Beckman Coulter, Inc. - Form 483, 2023-12-11

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