FDA Person
FDADiane M. Biron
View detailed information about Diane M. Biron, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 8 inspections of 6 companies, 2017–2024.
Inspections (8)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| November 26, 2024 | Atrium Medical Corporation | NAI | Postmarket Assurance: Medical Devices | #1232907 |
| June 5, 2024 | Integra LifeSciences Corporation | OAI | Compliance: Devices | #1230005 |
| February 16, 2024 | Professional Contract Sterilization, Inc. | VAI | Compliance: Devices | #1230474 |
| May 17, 2023 | TEI Biosciences, Inc. | OAI | Compliance: Devices | #1205514 |
| November 2, 2018 | TEI Biosciences, Inc. | OAI | Project Evaluation: Devices | #1070677 |
| August 2, 2018 | Atrium Medical Corporation | OAI | Project Evaluation: Devices | #1060821 |
| April 5, 2018 | Conseal International, Inc. | VAI | Drug Quality Assurance | #1046981 |
| June 13, 2017 | Flexion Therapeutics, Inc. | VAI | Compliance: Devices | #1013962 |
Documents (7)
- 483 · Integra LifeSciences Corporation · June 5, 2024
- 483 · Atrium Medical Corporation · November 26, 2024
- 483 · Beeken Biomedical, LLC · July 8, 2021
- 483 · TEI Biosciences, Inc. · November 12, 2021
- 483 · Professional Contract Sterilization, Inc. · February 16, 2024
- 483 · TEI Biosciences, Inc. · November 2, 2018
- 483 · TEI Biosciences, Inc. · May 17, 2023
Frequently inspected with (4)
Person Information
Name
Diane M. Biron
Role
ISSUING OFFICER
ID: 12eb885a-3ae3-449d-907e-36133dbdb194
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