FDA Person
FDAMichelle J. Glembin
View detailed information about Michelle J. Glembin, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 40 inspections of 36 companies, 2016–2025.
Inspections (40)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| August 29, 2025 | MEDLINE INDUSTRIES, LP - Northfield | Not classified | Compliance: Medical Devices | #1260204 |
| January 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield | OAI | Compliance: Devices | #1227453 |
| September 1, 2023 | APN Health LLC | NAI | Postmarket Assurance: Devices | #1216874 |
| May 4, 2023 | Suncoast Dental, Inc. dba Tatum Surgical | NAI | Postmarket Assurance: Devices | #1204632 |
| September 19, 2019 | Prism Clinical Imaging Inc. | VAI | Compliance: Devices | #1102345 |
| August 22, 2019 | Guy & O'Neill Inc. | VAI | Compliance: Devices | #1100729 |
| July 18, 2019 | DRAPER PRODUCTS, INC./R. SABEE CO. LLC | VAI | Compliance: Devices | #1096774 |
| July 17, 2019 | Little Rapids Corporation | VAI | Compliance: Devices | #1096775 |
| June 27, 2019 | Ad-Tech Medical Instrument Corporation | VAI | Compliance: Devices | #1095446 |
| May 7, 2019 | Team Innovations Inc. | VAI | Compliance: Devices | #1088809 |
| April 17, 2019 | Performance Health Supply LLC | VAI | Postmarket Assurance: Devices | #1087521 |
| March 12, 2019 | Preservation Solutions, Inc. | OAI | Compliance: Devices | #1082303 |
| February 8, 2019 | LOHMAN TECHNOLOGIES LLC | VAI | Compliance: Devices | #1079151 |
| January 29, 2019 | Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company | NAI | Compliance: Devices | #1080179 |
| January 22, 2019 | Nev's Ink Inc. | VAI | Compliance: Devices | #1077121 |
| December 12, 2018 | Atos Medical Inc | VAI | Postmarket Assurance: Devices | #1075468 |
| December 6, 2018 | Cornell LLC | NAI | Compliance: Devices | #1079059 |
| October 12, 2018 | Imaging Biometrics LLC | VAI | Postmarket Assurance: Devices | #1069058 |
| August 1, 2018 | Becton Dickinson Medical Systems | OAI | Compliance: Devices | #1061069 |
| April 13, 2018 | Somna Therapeutics LLC | NAI | Compliance: Devices | #1048851 |
Documents (25)
- 483 · InControl Medical, LLC · August 21, 2012
- 483 · Escalon Medical Corp. · November 25, 2019
- 483 · MEDLINE INDUSTRIES, LP - Northfield · January 22, 2024
- 483 · MEDLINE INDUSTRIES, LP - Northfield · August 29, 2025
- 483 · Creation Technologies Ltd · March 5, 2020
- 483 · Guy & O'Neill Inc. · August 22, 2019
- 483 · Nev's Ink Inc. · January 22, 2019
- 483 · Aesculap Inc · October 30, 2019
- 483 · Preservation Solutions, Inc. · September 30, 2021
- 483 · Prism Clinical Imaging Inc. · September 19, 2019
- 483 · Guy & O'Neill Inc. · October 29, 2021
- 483 · ST JUDE COSTA RICA LTDA. · February 27, 2020
- 483 · Vesta Inc. · October 20, 2017
- 483 · Performance Health Supply LLC · April 17, 2019
- 483 · DRAPER PRODUCTS, INC./R. SABEE CO. LLC · July 18, 2019
- 483 · Atos Medical Inc · December 12, 2018
- 483 · Little Rapids Corporation · July 17, 2019
- 483 · APN Health LLC · September 1, 2023
- 483 · Alcon Laboratories Ireland, Ltd · July 7, 2016
- 483 · Titan Spine, LLC · December 11, 2017
- 483 · Plas-Tech Engineering Inc. · January 24, 2011
- EIR · APN Health LLC · October 10, 2019
- 483 · APN Health LLC · October 10, 2019
- 483 · Team Innovations Inc. · May 7, 2019
- 483 · Bradshaw Medical, Inc. · August 15, 2017
Frequently inspected with (10)
Nicholas T. Domer
investigator
3 shared
Nicholas Z. Lu
2 shared
Christopher D. Leach
Compliance Officer at FDA
1 shared
Clifton L. Randell
Microbiologist
1 shared
Edward E. Lockwood
1 shared
Gisselle I. Sensebe
1 shared
Lisa T. Michel
Division Director at CDRH/OPEQ/Office of Regulatory Programs
1 shared
Mildred J. Tures
1 shared
Natasha R. Johnson
1 shared
Ross J. Grigsby
1 shared
Person Information
Name
Michelle J. Glembin
Title
investigator
Role
COMPANY REP
ID: e58f4652-d09f-41a7-941d-335c7b5338ad
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