FDA Person
FDAStephen R. Souza
View detailed information about Stephen R. Souza, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 84 inspections of 77 companies, 2016–2024.
Inspections (84)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| July 10, 2024 | Ameritek USA, Inc. | NAI | Postmarket Assurance: Devices | #1243511 |
| June 17, 2024 | Eye-Novation, LLC | OAI | Compliance: Devices | #1241517 |
| May 16, 2024 | TF Health Corp. | Not classified | Compliance: Devices | #1239629 |
| April 18, 2024 | Physio-Control, Inc. | NAI | Compliance: Devices | #1230558 |
| March 26, 2024 | Fukuda Denshi USA, Inc. | NAI | Compliance: Devices | #1235613 |
| March 6, 2024 | US Vascular, Inc. | NAI | Postmarket Assurance: Devices | #1232207 |
| February 2, 2024 | Northwest Eye Design, LLC | NAI | Postmarket Assurance: Devices | #1228543 |
| January 18, 2024 | Fluke Biomedical LLC | VAI | Postmarket Assurance: Devices | #1227243 |
| December 13, 2023 | Michelson Diagnostics Ltd | OAI | Compliance: Devices | #1226492 |
| December 7, 2023 | TR Equipment AB | VAI | Compliance: Devices | #1225119 |
| November 3, 2023 | Philips North America LLC | Not classified | #1221815 | |
| September 29, 2023 | Dexcom, Inc. | NAI | Compliance: Devices | #1220386 |
| August 23, 2023 | CurvaFix, Inc. | VAI | Postmarket Assurance: Devices | #1215697 |
| August 3, 2023 | Bio-Rad Laboratories, Inc. | NAI | Compliance: Devices | #1214980 |
| June 15, 2023 | Parks Medical Electronics, Inc | NAI | Postmarket Assurance: Devices | #1208261 |
| May 18, 2023 | ReNovo, Inc. | OAI | Compliance: Devices | #1205740 |
| May 10, 2023 | Modus Health, LLC | NAI | Postmarket Assurance: Devices | #1204964 |
| May 2, 2023 | Carrot Medical, LLC | NAI | Postmarket Assurance: Devices | #1204653 |
| April 4, 2023 | Toaster Labs, Inc. | VAI | Postmarket Assurance: Devices | #1201733 |
| March 10, 2023 | Medtronic MiniMed, Inc. | NAI | Postmarket Assurance: Devices | #1199488 |
Documents (45)
- 483 · Northwest Eye Design, LLC · February 2, 2024
- 483 · Medtronic MiniMed, Inc. · March 10, 2023
- 483 · Signature Orthopedics Pty Limited · July 2, 2018
- EIR · Centerchem · July 8, 2009
- 483 · Philips North America LLC · November 3, 2023
- 483 · Eye-Novation, LLC · June 17, 2024
- 483 · Percussionaire Corporation · August 25, 2022
- 483 · Philips North America LLC · August 20, 2021
- 483 · US Vascular, Inc. · March 6, 2024
- 483 · Lacrimedics Inc · January 23, 2020
- 483 · G. Dundas Co Inc · August 8, 2019
- 483 · Virginia Mason Medical Center · April 15, 2016
- 483 · PatCen Healthcare Inc. · January 14, 2020
- 483 · Parks Medical Electronics, Inc · June 15, 2023
- 483 · I.T.S. GmbH · May 3, 2019
- 483 · Strata Skin Sciences, Inc. · September 30, 2021
- 483 · SurgiMark, Inc. · August 8, 2017
- 483 · US Vascular, Inc. · March 30, 2018
- 483 · Physio-Control, Inc. · November 26, 2019
- 483 · Hummingbird Med Devices, Inc. · August 26, 2019
- 483 · AQUISEL S.L.U. · May 15, 2019
- 483 · Flextronics Romania Srl · May 11, 2017
- 483 · Ventec Life Systems, Inc. · July 27, 2022
- 483 · BioMed Diagnostocs, Inc · May 6, 2022
- 483 · TR Equipment AB · December 7, 2023
- 483 · Siemens Medical Solutions USA, Inc. · January 6, 2023
- 483 · Modus Health, LLC · May 10, 2023
- 483 · InBios International, Inc. · June 16, 2022
- 483 · Signature Orthopedics Pty Limited · July 5, 2018
- 483 · CurvaFix, Inc. · August 23, 2023
- 483 · Magnolia Medical Technologies, Inc. · July 15, 2021
- 483 · ReNovo, Inc. · May 18, 2023
- 483 · AMT Medical · December 13, 2019
- 483 · Spacelabs Healthcare, Inc. · September 15, 2022
- 483 · Micro Current Technology, Inc. · January 28, 2019
- 483 · Toaster Labs, Inc. · April 4, 2023
- 483 · Asteelflash Design Solutions Hamburg GmbH · May 9, 2019
- 483 · Creation Technologies · September 10, 2019
- 483 · Organ Eco Tech · February 27, 2020
- 483 · Good Clean Love, Inc. · June 13, 2019
- EIR · Pfizer Inc. · April 30, 2012
- 483 · Philips North America LLC · October 27, 2022
- EIR · Pfizer Inc. · February 24, 2012
- 483 · Fluke Biomedical LLC · January 18, 2024
- 483 · Silgan Unicep Packaging LLC · February 28, 2014
Frequently inspected with (10)
Christopher S. Genther
investigator
6 shared
Brian R. Hendricks
3 shared
Juanj Wu
2 shared
Paul M. Kawamoto
issuing_officer
2 shared
Creighton T. Tuzon
1 shared
Elizabeth A. Dakan
investigator
1 shared
James D. Hildreth
President and CEO
1 shared
Jeremy L Stukes
1 shared
Marlo-Ian M. Alintanahin
1 shared
Matthew M. Vernon
investigator
1 shared
Person Information
Name
Stephen R. Souza
Role
INVESTIGATOR
ID: 9b7af4df-f1cc-468d-9761-cee11d3c14fc
Get More Insights
Access our comprehensive quality intelligence platform to analyze patterns, track compliance trends, and stay ahead of regulatory changes.
1.5M+ regulatory data points
Real-time compliance monitoring
Interactive analytics dashboard
Looking for more people? Our platform provides access to thousands of FDA people with advanced search and filtering capabilities.
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.