FDA Person
FDAChristina L. Bigham
View detailed information about Christina L. Bigham, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 87 inspections of 84 companies, 2016–2026.
Inspections (87)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| July 17, 2026 | Isomedix Operations Inc. | Not classified | Project Evaluation: Devices | #1327498 |
| April 1, 2026 | Minnetronix, Inc. | Not classified | Project Evaluation: Devices | #1310502 |
| March 4, 2026 | Radiation Products Design,Inc | NAI | Postmarket Assurance: Medical Devices | #1306546 |
| January 15, 2026 | MEDTRONIC ATS MEDICAL, INC. | Not classified | Compliance: Medical Devices | #1299282 |
| November 12, 2025 | Gyrus ACMI, Inc. | Not classified | Compliance: Medical Devices | #1295532 |
| September 15, 2025 | Athena Surgical | NAI | Compliance: Devices | #1285132 |
| September 10, 2025 | J&J Machine Inc. | Not classified | #1285020 | |
| August 14, 2025 | Benchmark Electronics Inc | Not classified | Product Evaluation: Medical Devices | #1278446 |
| July 2, 2025 | Envoy Medical Corporation | OAI | Compliance: Medical Devices | #1276707 |
| May 22, 2025 | Clarus Medical, Llc | NAI | Postmarket Assurance: Medical Devices | #1270474 |
| April 7, 2025 | Boston Scientific Corporation | OAI | Compliance: Medical Devices | #1257844 |
| February 20, 2025 | Sewoon Medical Co., Ltd. | OAI | Compliance: Medical Devices | #1261809 |
| February 13, 2025 | Tae-Chang Industrial Co., Ltd. | NAI | Postmarket Assurance: Medical Devices | #1261808 |
| February 13, 2025 | Tae-Chang Industrial Co., Ltd. | VAI | Compliance: Devices | #1261808 |
| February 6, 2025 | GEMSS HEALTHCARE CO., LTD. | NAI | Postmarket Assurance: Medical Devices | #1261807 |
| January 24, 2025 | Junopacific Inc. | NAI | Postmarket Assurance: Medical Devices | #1261810 |
| November 27, 2024 | Augustine Temperature Management, LLC | OAI | Compliance: Medical Devices | #1256855 |
| October 28, 2024 | NeuroOne Medical Technologies Corporation | NAI | Postmarket Assurance: Medical Devices | #1252882 |
| September 30, 2024 | South Dakota Partners Inc | VAI | Product Evaluation: Medical Devices | #1250703 |
| August 22, 2024 | Model Solution | VAI | Compliance: Devices | #1247573 |
Documents (55)
- 483 · Philips Medical Systems (Cleveland) Inc · August 18, 2017
- 483 · Biomet, Inc. · April 24, 2018
- EIR · Medtronic Neuromodulation · May 5, 2023
- EIR · Cintas Corporation · June 24, 2016
- 483 · Gyrus ACMI, Inc. · November 12, 2025
- 483 · Medtronic Neuromodulation · May 5, 2023
- 483 · Envoy Medical Corporation · July 2, 2025
- EIR · InTheSmart Co., Ltd. · February 12, 2019
- 483 · Junopacific Inc. · January 24, 2025
- 483 · NeuroOne Medical Technologies Corporation · October 28, 2024
- 483 · Benchmark Electronics Inc · August 14, 2025
- 483 · Exercore, LLC · September 2, 2021
- 483 · Biomerieux Inc · August 20, 2019
- 483 · Biomerics LLC · August 25, 2023
- EIR · Inspire Medical Corp. · May 10, 2024
- 483 · Augustine Temperature Management, LLC · November 27, 2024
- 483 · South Dakota Partners Inc · September 30, 2024
- EIR · Ethicon Endo-Surgery Inc · May 26, 2017
- 483 · Clarus Medical, Llc · May 22, 2025
- 483 · Plaxtron Industrial (M) SDN. BHD. · August 15, 2024
- 483 · Beckman Coulter, Inc. · December 11, 2023
- 483 · Annex Medical, Inc. · June 9, 2023
- 483 · Access Point Technologies EP, Inc. · December 20, 2022
- 483 · Integra LifeSciences Corporation · July 2, 2018
- 483 · Bionet Co., Ltd. · February 18, 2019
- 483 · Iowa Adaptive Technologies Inc. · July 11, 2019
- 483 · Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.) · April 24, 2019
- 483 · Inspire Medical Systems Inc. · May 10, 2024
- 483 · Nightware · July 1, 2024
- 483 · Spineology, Inc. · February 15, 2022
- 483 · Smiths Medical ASD, Inc. · March 3, 2023
- 483 · Smiths Medical ASD, Inc. · April 30, 2021
- 483 · rms Company · May 18, 2022
- 483 · LISI MEDICAL Remmele, Inc · July 12, 2022
- 483 · BEYOND AIR · September 23, 2021
- 483 · Advance-Esthetic LLC · February 7, 2024
- 483 · Scapa Tapes North America LLC · June 17, 2022
- 483 · Surface Dynamics LLC · September 26, 2018
- EIR · MHC Medical Products LLC · February 2, 2018
- EIR · Scapa Tapes North America LLC · June 17, 2022
- 483 · Titronics Research & Development Co. · July 9, 2019
- 483 · MHC Medical Products LLC · February 2, 2018
- 483 · Spartronics Watertown LLC · October 28, 2021
- EIR · Surface Dynamics LLC · September 26, 2018
- 483 · Lifecore Biomedical LLC · January 21, 2021
- 483 · Collaborative Care Diagnostics, LLC dba BioMedix · October 18, 2021
- 483 · Starkey Laboratories Inc · November 13, 2018
- 483 · Crest Electronics Inc · December 28, 2022
- 483 · Taurus Engineering and Manufacturing, Inc. · March 10, 2022
- 483 · Primus Corporation dba Trinity Biotech · February 6, 2020
- 483 · Boston Scientific Corporation · April 7, 2025
- 483 · Medtronic Neuromodulation · November 3, 2022
- 483 · MEDTRONIC ATS MEDICAL, INC. · January 15, 2026
- 483 · Radiation Products Design,Inc · March 4, 2026
- 483 · Electromed, Inc. · February 12, 2026
Frequently inspected with (10)
Person Information
Name
Christina L. Bigham
Title
Investigator
Role
Regulatory Personnel
ID: f3da8e26-4a8c-43a8-8070-349fe4500289
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.