FDA Investigator David H Smith

David H Smith has conducted inspections on 143 sites in 13 countries as of 27 Jun 2022. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
143
Last Inspection Date:
27 Jun 2022
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Singapore, China, United States of America, Germany, Malaysia, Korea (Republic of), Canada, Taiwan, United Kingdom of Great Britain and Northern Ireland, Iceland, India, Slovakia, Ireland
FDA Investigators that have inspected at least one site in common with David H Smith:
Alan D Centi, Alberto A Viciedo, Althea A Williams, Amanda S Zorn, Amy A Johnson, Amy L Singer, Amy M Cramer, Andrew J Molesky, Anthony M Criscuolo, Jr, Arie C Menachem, Arsen Karapetyan, Barbara J Maulfair, Barbara Jwilimczyk Macri, Byungja E Marciante, Camerson E Moore, Cara M Minelli, Cary Greene, Catherine J Laufmann, CDR Sean T Creighton, Charles J Chacko, Christina N Maurino, Christine M Parmentier, Craig W Swanson, David P Vanhouten, David R Delucia, Dawn L Wydner, Deborah B Nixon, Demitria J Xiradakis, Denise M Visco, Investigator, Dhaval H Patel, Diane B Radice, Dipesh K Shah, Dolores Harper, Donna Ltartaglino Besone, Doreen P Canetti, Doreen P Gubbay, Douglas C Kovacs, Dung N Tran, Edward O'shaughnessy, Eileen A Liu, Ellen J Tave, Emest F Bizjak, Emmanuel Jramos Maldonado, Eric J Cunningham, Eric Rothschild, Eric S Pittman, Erin D Mccaffery, Erin L Mcfiren, Esteban Beltran, Frank J Marciniak, Gamal A Norton, Gianine E Delade, Gianine E Tompkins, Gobiga Vanniyasingam, Gregson A Joseph, Helen B Ricalde, Helen Verdel, Jacqueline S Warner, James D Planchon, James R Birkenstamm, James R Montero, James W Plucinski, Jason M Sluzynski, Jean M Kelahan, Jennifer A Bazergui, Jennifer L Custodio, Jessica M Monteiro, John A Sciacchitano, Jonathan Ho, Jonee J Mearns, Jose M Cayuela, Jose V Obando, Joseph S Fanelli, Justine Tomasso, Karen E D'orazio, Karen F Tomaziefski, Kazi Rafiquzzaman, Keith M Reilly, Kelli F Dobilas, Kelly D Sheppard, Kelly Doremus, Kelly I Anderson, Kerry A Kurdilla, Kim M Downing, Kimberly Lewandowski Walker, Kinh Q Mac, Kristen E Rescigno, Kristy A Zielny, Krystal O Ogunremi, Laishan L Lam, Laiza V Garcia, Lauren E Priest, Lauren L Vajo, Lawrence R Johnson, Li Li, Liatte Kreuger, PharmD, Lisa B Hall, Lisa Harlan, Lisa Mathew, Loretta Nemchik, LT Colin E Tack, BSE, Lydia S Chan, Malik S Qaiser, Marcelo O Mangalindan, Jr, Margaret M Sands, Marijo B Kambere, PhD, Marjorie D Schultz, Mark E Chan, Matthew A Spataro, Matthew W Kyle, Melba Trivera Clavell, Melissa A Freeman, Melissa A Zuppe, Melissa B Libby, Melissa T Roy, Meredith L Sheridan, Michael Serrano, Michele C Murray Schrade, Michelle L Johnson, Miguel Gmanzano Maldonado, Minh D Phan, Monica L Gutierrez, Naakesh N Gomanie, Namita Kothary, Paola S Barnett, Patrick B Cummings, Peter R Lenahan, Ralph Jerndal, Remache, Richard A Abate, Richard D Manney, Richard L Rutherford, Robert G Ruff, Rodrigo Vilchez, Ronald Ifraimov, Roy Baby, Russell J Glapion, Saied A Asbagh, Sandra Kershaw, Sarah Forney, Schultz, Sherri J Liu, Simone E Pitts, Sinai I Davis, Spiridoula Dimopoulos, Stephanie T Durso, Stephen D Eich, Stephen J Mottola, Steven M Weinman, Susan M Halsted, Tania E Garcia, Tania E Vizcaino, Teigan M Mule, Thai T Duong, Tonia F Bernard, Tressa T Lewis, Tyanna N Hadley, Valerie C Reed, Victor Spanioli, Vincent T Duncan, Wendy R Blame, William R Chang, Wilmarie Marrero Santiago, Yasmin B Rios, Yehualashet A Gessesse, Yvesna C Blaise, Zakaria I Ganiyu

David H Smith's Documents

Publish Date Document Type Title
February, 2013 FDA 483 Mako Surgical Corporation - Form 483, 2013-02-26
June, 2017 FDA 483 Diasol Inc - Form 483, 2017-06-15
September, 2018 FDA 483 Pentax of America Inc - Form 483, 2018-09-27
September, 2012 FDA 483 James Alexander Corporation - Form 483, 2012-09-10
August, 2021 FDA 483 Blickman Industries LLC - Form 483, 2021-08-20
April, 2014 FDA 483 Airways Development LLC - Form 483, 2014-04-09
June, 2017 FDA 483 Response Diasol Inc - Form 483R, 2017-07-31
April, 2014 EIR Airways Development LLC - EIR, 2014-04-09
October, 2015 EIR LRM Packaging, Inc. - EIR, 2015-10-25
July, 2022 FDA 483 Specialty Vision Llc - Form 483, 2022-07-07
January, 2013 FDA 483 Beaver-Visitec International, Inc. - Form 483, 2013-01-11
March, 2019 FDA 483 P.C. Marketing, Inc. - Form 483, 2019-03-07
May, 2016 FDA 483 Bausch Health Companies, Inc. - Form 483, 2016-05-17
October, 2018 EIR Becton Dickinson Medical (Singapore) - EIR, 2018-10-25
May, 2016 EIR Bausch Health Companies, Inc. - EIR, 2016-05-17
April, 2014 FDA 483 Response Airways Development LLC - Form 483R, 2014-04-18
April, 2011 FDA 483 Response Maquet Cardiovascular, LLC - Form 483R, 2011-08-30
July, 2021 FDA 483 Medlink Imaging, LLC - Form 483, 2021-07-26
March, 2015 FDA 483 Mindray DS USA, Inc. dba Mindray North America - Form 483, 2015-03-10
November, 2010 EIR Queseria Chipilo, Inc. - EIR, 2010-11-08
February, 2020 FDA 483 The Snore Reliever Company LLC - Form 483, 2020-02-05
January, 2017 FDA 483 P.C. Marketing, Inc. - Form 483, 2017-01-19
April, 2011 FDA 483 Maquet Cardiovascular, LLC - Form 483, 2011-04-01

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