FDA Person
FDAMonica L. Gutierrez
View detailed information about Monica L. Gutierrez, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 36 inspections of 32 companies, 2023–2026.
Inspections (36)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 11, 2026 | IMPULSE DYNAMICS USA INC | Not classified | #1338700 | |
| August 13, 2026 | Saalmann Medical Gmbh & Co Kg | Not classified | #1333922 | |
| May 27, 2026 | Neurometrix, Inc. | Not classified | Compliance: Devices | #1319250 |
| April 24, 2026 | Cosmed of New Jersey | Not classified | Compliance: Devices | #1313802 |
| March 27, 2026 | DSRV, Inc | Not classified | Compliance: Medical Devices | #1309570 |
| December 3, 2025 | ASEPTIKITS, LLC | Not classified | Compliance: Medical Devices | #1288994 |
| November 11, 2025 | Scientia Vascular, Inc. | VAI | Compliance: Medical Devices | #1290968 |
| November 5, 2025 | B & D Dental Corp. | NAI | Postmarket Assurance: Medical Devices | #1290318 |
| October 23, 2025 | Prosidyan Inc | Not classified | #1296690 | |
| September 9, 2025 | Diagnostica Stago, Inc. | Not classified | #1282318 | |
| August 14, 2025 | Allurion Technologies, Inc. | NAI | Postmarket Assurance: Devices | #1279648 |
| June 26, 2025 | Technocom Systems Sdn. Bhd. | VAI | Compliance: Medical Devices | #1273809 |
| June 26, 2025 | Technocom Systems Sdn Bhd | VAI | Postmarket Assurance: Devices | #1273809 |
| June 19, 2025 | DongBang Medical Co. Ltd. | Not classified | #1286936 | |
| June 12, 2025 | WINBACK GO EAST CO LTD | NAI | Postmarket Assurance: Medical Devices | #1272426 |
| May 29, 2025 | Jersey Dental Supplies | VAI | Compliance: Medical Devices | #1271366 |
| April 16, 2025 | Artegraft, Inc. | OAI | Compliance: Medical Devices | #1235542 |
| February 20, 2025 | Titan Implants, Inc | NAI | Postmarket Assurance: Medical Devices | #1261614 |
| January 21, 2025 | Z7 LLC | NAI | Postmarket Assurance: Medical Devices | #1258772 |
| January 14, 2025 | Peace Medical Inc. | NAI | Postmarket Assurance: Medical Devices | #1258337 |
Documents (20)
- 483 · Z7 LLC · January 21, 2025
- 483 · Artegraft, Inc. · April 16, 2025
- 483 · Titan Implants, Inc · February 20, 2025
- 483 · Diagnostica Stago, Inc. · September 4, 2024
- 483 · LeMaitre Vascular, Inc. · October 18, 2023
- 483 · Turncare, Inc · December 11, 2024
- 483 · Jersey Dental Supplies · May 29, 2025
- 483 · Peace Medical Inc. · January 14, 2025
- 483 · Biocore9 Llc · November 6, 2023
- 483 · Turncare, Inc · June 26, 2023
- 483 · Wand Dental Inc. · December 21, 2023
- 483 · Almark Tool & Manufacturing Company, Inc. · February 7, 2023
- 483 · Ingen Orthopedics LLC · May 3, 2023
- 483 · Micro Stamping Corp · January 18, 2023
- 483 · Virak Orthopedics LLC · August 25, 2023
- 483 · Titan Implants, Inc · March 16, 2023
- 483 · ASEPTIKITS, LLC · December 3, 2025
- 483 · LeMaitre Vascular, Inc. · August 24, 2023
- 483 · Neurometrix, Inc. · May 27, 2026
- 483 · Cosmed of New Jersey · April 24, 2026
Frequently inspected with (9)
Person Information
Name
Monica L. Gutierrez
Role
ISSUING OFFICER
ID: fe60f8c6-ad1b-4619-9903-ed7be6d3bf7d
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