FDA Person
FDAStephen C. Smith
View detailed information about Stephen C. Smith, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 50 inspections of 49 companies, 2016–2023.
Inspections (50)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| March 30, 2023 | Agilent Technologies, Inc | NAI | Compliance: Devices | #1202667 |
| February 22, 2023 | AADCO Medical Inc. | VAI | Compliance: Devices | #1198080 |
| February 6, 2023 | SoClean, Inc | VAI | Postmarket Assurance: Devices | #1196601 |
| July 25, 2019 | Vitalconnect Inc. | NAI | Postmarket Assurance: Devices | #1097585 |
| July 18, 2019 | Gauss Surgical, Inc. | VAI | Compliance: Devices | #1096683 |
| June 21, 2019 | FUJIFILM Healthcare Americas Corporation | VAI | Compliance: Devices | #1095860 |
| May 30, 2019 | CathWear, LLC | VAI | Compliance: Devices | #1091123 |
| April 10, 2019 | InfoBionic, Inc. | VAI | Compliance: Devices | #1085891 |
| April 2, 2019 | Elucid Bioimaging Inc. | VAI | Compliance: Devices | #1084923 |
| February 28, 2019 | Hitachi High-Technologies Corp., Omuta Center | Not classified | Project Evaluation: Devices | #1081543 |
| February 21, 2019 | Shanghai JPY Ion-Tech Co., Ltd. | VAI | Project Evaluation: Devices | #1081542 |
| January 24, 2019 | iCAD, Inc. (formerly VuCOMP, Inc.) | NAI | Compliance: Devices | #1079214 |
| December 11, 2018 | OPKO Diagnostics, LLC | VAI | Project Evaluation: Devices | #1074293 |
| November 14, 2018 | Anuncia, Inc. | VAI | Compliance: Devices | #1071623 |
| November 9, 2018 | Bio-Signal Group Corp. | VAI | Compliance: Devices | #1071458 |
| September 13, 2018 | Penlon Limited | VAI | Compliance: Devices | #1065790 |
| September 6, 2018 | Inmo-Tech Ltd. | NAI | Compliance: Devices | #1070747 |
| August 30, 2018 | Kammerer Medical Systems GmbH & Co. KG | Not classified | Compliance: Devices | #1063840 |
| August 2, 2018 | Atrium Medical Corporation | OAI | Project Evaluation: Devices | #1060821 |
| June 18, 2018 | Catalent Massachusetts, LLC | NAI | Compliance: Devices | #1056145 |
Documents (25)
- EIR · Benchmark Electronics, Inc. · August 26, 2020
- 483 · Dartmouth Hitchcock Medical Center · December 17, 2015
- 483 · Brigham and Women's Hospital · December 10, 2015
- WARNING LETTER · K Va T Food Stores · March 1, 2016
- 483 · Nypro FinPack · March 21, 2014
- 483 · Nypro Clinton · March 17, 2017
- 483 · ATC Technologies, Inc. · October 7, 2019
- 483 · AADCO Medical Inc. · February 22, 2023
- 483 · Evoqua Water Technologies, LLC · February 24, 2022
- 483 · Teledyne Flir Commercial Systems, Inc. · October 4, 2022
- 483 · Atrium Medical Corporation · August 2, 2018
- EIR · Nypro FinPack · March 21, 2014
- 483 · SoClean, Inc · February 6, 2023
- 483 · TEI Biosciences, Inc. · November 12, 2021
- 483 · Gauss Surgical, Inc. · July 18, 2019
- 483 · Centro de Construccion de Cardioestimuladores del Uruguay SA · August 18, 2022
- 483 · CooperSurgical, Inc. · July 15, 2021
- 483 · CDR SYSTEMS, INC. · August 11, 2022
- 483 · Allergen Medical · July 7, 2015
- 483 · Breas Medical, Inc. · February 6, 2020
- EIR · Biotechne, Inc. · June 20, 2017
- 483 · Atrium Medical Corporation · October 1, 2013
- 483 · Hitachi High-Technologies Corp., Omuta Center · February 28, 2019
- 483 · Desarrollo E Investigacion Medica Aragonesa SL · December 19, 2019
- 483 · Benchmark Electronics, Inc. · August 26, 2020
Person Information
Name
Stephen C. Smith
Title
Investigator
Role
Regulatory Personnel
ID: 426649fa-0e5b-4b35-ba41-636512a06a48
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