FDA Person
FDAMonica C. Burgos Garcia
View detailed information about Monica C. Burgos Garcia, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 79 inspections of 76 companies, 2016–2026.
Inspections (79)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 25, 2026 | Becton Dickinson Caribe LTD | Not classified | #1340334 | |
| August 27, 2026 | EEG Software LLC | VAI | Postmarket Assurance: Devices | #1333128 |
| August 25, 2026 | MLM Biologics, Inc. | VAI | Compliance: Devices | #1332564 |
| July 30, 2026 | Cardiocommand Inc. | NAI | Postmarket Assurance: Devices | #1328654 |
| May 29, 2026 | Otto Bock Healthcare Products GmbH | Not classified | #1309056 | |
| May 21, 2026 | OD-OS GmbH | Not classified | #1323728 | |
| May 14, 2026 | Synergy Health Sterilisation UK Ltd | Not classified | #1322576 | |
| March 24, 2026 | Linvatec Corp. dba ConMed Linvatec | Not classified | Compliance: Medical Devices | #1309064 |
| February 20, 2026 | Stryker Puerto Rico, LLC | VAI | Compliance: Medical Devices | #1303670 |
| December 5, 2025 | Safesource Direct Glove Plant | NAI | Postmarket Assurance: Medical Devices | #1294144 |
| December 5, 2025 | Safesource Direct LLC | NAI | Postmarket Assurance: Medical Devices | #1294142 |
| November 6, 2025 | Advance-Esthetic LLC | Not classified | Compliance: Medical Devices | #1280825 |
| October 17, 2025 | DS REP B.V. | NAI | Postmarket Assurance: Devices | #1288064 |
| September 19, 2025 | Abbott Medical | NAI | Bioresearch Monitoring | #1276721 |
| August 21, 2025 | GVS Puerto Rico LLC | Not classified | #1281110 | |
| August 1, 2025 | Hill-Rom Inc. | NAI | Postmarket Assurance: Devices | #1280287 |
| July 24, 2025 | Custom Assemblies, Inc. | NAI | Compliance: Devices | #1277633 |
| June 26, 2025 | Laser Engineering, Inc. | NAI | Compliance: Devices | #1276634 |
| May 21, 2025 | ClearCam Inc. | Not classified | #1272199 | |
| May 16, 2025 | Maestro Logistics LLC | NAI | Compliance: Devices | #1272056 |
Documents (38)
- 483 · Pelican Feminine Healthcare DBA Single Use Surgical · July 2, 2018
- 483 · Pennine Healthcare · July 5, 2018
- EIR · Patheon Manufacturing Services LLC · March 28, 2018
- EIR · Medtronic Puerto Rico Operations Co. · October 25, 2019
- 483 · Coeur, Inc. · March 29, 2018
- 483 · MobileHelp, LLC · March 11, 2022
- 483 · Oscor Inc. · September 20, 2019
- 483 · Coeur Inc. · March 29, 2018
- 483 · Customed, Inc. · October 4, 2024
- 483 · 3D Medical Manufacturing, Inc. · June 23, 2023
- 483 · Becton Dickinson Caribe LTD · March 11, 2020
- 483 · NeuroVention, LLC · May 31, 2023
- 483 · Clear Choice Therapeutics, Inc. · May 11, 2023
- 483 · SterCUBE Surgical Systems LLC · March 17, 2023
- 483 · Bleep, LLC · August 25, 2023
- 483 · Nyx Inc. · November 17, 2023
- 483 · Wu's Tech Co., Ltd. · August 30, 2018
- 483 · Gulf Fiberoptics, Inc. · March 23, 2023
- EIR · Sun Pharmaceutical Industries Ltd. · June 11, 2019
- 483 · Cantor & Barnard Ltd. · June 28, 2018
- 483 · Ensemble Orthopedics, Inc. · August 4, 2023
- 483 · Becton Dickinson Caribe LTD · November 23, 2021
- 483 · North American Diagnostics · June 23, 2022
- 483 · Eakin Surgical Ltd · July 5, 2018
- 483 · Medtronic Puerto Rico Operations Co. · October 25, 2019
- 483 · Oscor Inc. · September 10, 2021
- 483 · Dr. Reddy's Laboratories Ltd. · June 21, 2019
- 483 · Bard Shannon Limited · November 21, 2018
- 483 · North American Medical Corp. (NAM) · December 9, 2022
- 483 · Sun Pharmaceutical Industries Ltd. · June 11, 2019
- EIR · Becton Dickinson Caribe LTD · July 29, 2021
- 483 · Kwang Yang Motor Co., Ltd. · August 16, 2018
- 483 · Jia Ding Precision Industry Co., Ltd. · August 22, 2018
- 483 · Advance-Esthetic LLC · November 6, 2025
- 483 · Safesource Direct Glove Plant · December 5, 2025
- 483 · Linvatec Corp. dba ConMed Linvatec · March 24, 2026
- 483 · Cardiocommand Inc. · July 30, 2026
- 483 · Stryker Puerto Rico, LLC · February 20, 2026
Frequently inspected with (10)
Maricelys Mercado
investigator
3 shared
Nydia E. Colon
3 shared
Farhana Khan
Food and Nutration Service
2 shared
Lashawn M. Elam
2 shared
Jacey Roy
1 shared
Jacob G. Lutz
Investigator
1 shared
Joohi Castelvetere
1 shared
Karen M. Cruz Arenas
1 shared
Lorraine N. Williams
1 shared
Rebecca E. Dowd
Director of Investigations Branch
1 shared
Person Information
Name
Monica C. Burgos Garcia
ID: d73d6ad6-4158-4c12-a0bf-6f5721db3400
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