FDA Person
FDALaureen M. Geniusz
View detailed information about Laureen M. Geniusz, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 90 inspections of 73 companies, 2016–2026.
Inspections (90)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 22, 2026 | Viscus Biologics LLC | VAI | Compliance: Devices | #1336816 |
| September 1, 2026 | Beacon Bio Dx LLC | NAI | Postmarket Assurance: Devices | #1333866 |
| August 13, 2026 | ECLOSION | VAI | Compliance: Devices | #1330786 |
| August 4, 2026 | Perma Laboratories LLC | VAI | Compliance: Devices | #1329294 |
| July 20, 2026 | Cleveland Diagnostics, Inc | NAI | Postmarket Assurance: Devices | #1327210 |
| June 29, 2026 | TT Electronics | VAI | Compliance: Devices | #1324154 |
| June 11, 2026 | Surgical Theater Inc | NAI | Postmarket Assurance: Devices | #1321540 |
| May 27, 2026 | SPR Therapeutics Inc. | NAI | Postmarket Assurance: Devices | #1320048 |
| May 6, 2026 | Marlen Manufacturing & Development Co. | VAI | Compliance: Devices | #1315724 |
| March 31, 2026 | MP Biomedicals Diagnostics Division | Not classified | Compliance: Medical Devices | #1310200 |
| March 25, 2026 | Consolidated Research, Inc. DBA General Sleep Corporation | Not classified | Compliance: Medical Devices | #1309448 |
| March 12, 2026 | Great Lakes Neurotechnologies Inc | NAI | Postmarket Assurance: Medical Devices | #1306918 |
| February 27, 2026 | Compass Health Brands Corp. | VAI | Compliance: Medical Devices | #1304696 |
| February 10, 2026 | Ricoh 3D for Healthcare LLC | NAI | Postmarket Assurance: Devices | #1304160 |
| December 18, 2025 | ProHealth Inc. | VAI | Compliance: Devices | #1295860 |
| December 18, 2025 | Pro2Health, Inc. | VAI | Compliance: Medical Devices | #1295860 |
| November 18, 2025 | S4 Medical Corp | NAI | Postmarket Assurance: Medical Devices | #1291752 |
| October 30, 2025 | Laser Therapy Services, LLC | NAI | Compliance: Devices | #1290432 |
| October 20, 2025 | Kent Elastomer Products Inc | Not classified | #1289122 | |
| October 20, 2025 | Kent Elastomer Products Inc | NAI | Compliance: Devices | #1289122 |
Documents (34)
- 483 · Philips Medical Systems (Cleveland) Inc · August 18, 2017
- EIR · MIM Software Inc · March 27, 2015
- EIR · Checkpoint Surgical Inc · March 15, 2018
- EIR · Bio-Thesiometer USA · January 19, 2018
- 483 · Invacare Corporation · January 31, 2020
- 483 · Codonics Inc · March 21, 2025
- 483 · Pro2Health, Inc. · December 18, 2025
- 483 · Alltech Medical Systems America Inc · July 29, 2019
- 483 · Invacare Corporation · June 24, 2021
- 483 · Surgtech Inc · May 7, 2025
- 483 · Lazurite Inc. · February 7, 2025
- 483 · Criterion Tool & Die Inc · February 17, 2023
- EIR · Philips Medical Systems (Cleveland) Inc · June 4, 2019
- 483 · SPR Therapeutics Inc. · February 22, 2018
- 483 · Frantz Medical Development Ltd · September 24, 2018
- 483 · Steris Corporation · March 13, 2020
- 483 · Philips Medical Systems (Cleveland) Inc · November 26, 2019
- 483 · Ekso Bionics Inc. · December 21, 2023
- 483 · Frantz Medical Development Ltd · June 27, 2023
- 483 · Invacare Corporation · March 30, 2023
- 483 · Design and Services Hub · September 8, 2025
- 483 · Kent Elastomer Products Inc · October 16, 2025
- 483 · Synapse Biomedical Inc · October 7, 2020
- 483 · CIT Ortho · September 5, 2023
- 483 · Checkpoint Surgical Inc · March 15, 2018
- 483 · Bio-Thesiometer USA · January 19, 2018
- 483 · Philips Medical Systems (Cleveland) Inc · June 4, 2019
- 483 · Beacon Bio Dx LLC · July 28, 2023
- 483 · Compass Health Brands Corp. · February 27, 2026
- 483 · Great Lakes Neurotechnologies Inc · March 12, 2026
- 483 · TT Electronics · June 29, 2026
- 483 · Surgical Theater Inc · June 11, 2026
- 483 · Consolidated Research, Inc. DBA General Sleep Corporation · March 25, 2026
- 483 · Marlen Manufacturing & Development Co. · May 6, 2026
Frequently inspected with (10)
Benjamin J. Dastoli
Investigator
9 shared
Christina L. Bigham
Investigator
3 shared
David J. Gasparovich
3 shared
John E. Marszalek
2 shared
Katelyn A. Staub-Zamperini
2 shared
Amber M. Capello-Jones
1 shared
Felicia E. Armbrustmacher
investigator
1 shared
Matthew A. Humbard
investigator
1 shared
Rosanna M. Goodrich
Medical Device Specialist
1 shared
Teresa K. Kastner
1 shared
Person Information
Name
Laureen M. Geniusz
Title
Investigator
Role
Regulatory Personnel
ID: 759a858e-e3f3-4c48-8194-9804c7ab2a7b
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