FDA Person
FDAFrank J. Marciniak
View detailed information about Frank J. Marciniak, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 62 inspections of 58 companies, 2016–2026.
Inspections (62)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 24, 2026 | CARDINAL HEALTH GERMANY | Not classified | Postmarket Assurance: Devices | #1338224 |
| September 17, 2026 | MERIDIAN MEDICAL DOO | Not classified | Compliance: Devices | #1338222 |
| September 10, 2026 | SYNERGIE NEDERLAND BV | Not classified | Postmarket Assurance: Devices | #1338226 |
| August 10, 2026 | Enterix, Inc. | VAI | Postmarket Assurance: Devices | #1330540 |
| July 17, 2026 | Ingenus Pharmaceuticals NJ, LLC. | Not classified | Compliance: Devices | #1326668 |
| June 25, 2026 | Artegraft, Inc. | Not classified | Compliance: Devices | #1325342 |
| March 31, 2026 | IVIMEA LLC | Not classified | Compliance: Medical Devices | #1311588 |
| February 13, 2026 | Accupac, Llc | VAI | Compliance: Medical Devices | #1261222 |
| November 19, 2025 | EDDA Technology, Inc. | Not classified | #1297886 | |
| September 25, 2025 | Sterigenics UK Limited | NAI | Postmarket Assurance: Medical Devices | #1284258 |
| September 18, 2025 | ANDERSEN CALEDONIA LTD | NAI | Postmarket Assurance: Medical Devices | #1284256 |
| September 11, 2025 | HPF S.P.A | NAI | Postmarket Assurance: Medical Devices | #1284260 |
| August 29, 2025 | Careox, Llc | NAI | Postmarket Assurance: Medical Devices | #1280202 |
| August 19, 2025 | DGI Group LLC | NAI | Postmarket Assurance: Medical Devices | #1279389 |
| July 25, 2025 | Richmond Diagnostics, Inc. | NAI | Postmarket Assurance: Medical Devices | #1276689 |
| June 24, 2025 | Fermatex Vascular Technologies | VAI | Compliance: Medical Devices | #1274466 |
| May 27, 2025 | SpaceBander Corporation | VAI | Compliance: Medical Devices | #1271168 |
| April 16, 2025 | Artegraft, Inc. | OAI | Compliance: Medical Devices | #1235542 |
| February 3, 2025 | Lingraphicare America, Inc. | VAI | Compliance: Medical Devices | #1261187 |
| December 6, 2024 | Advanced Tactile Imaging, Inc. | VAI | Compliance: Medical Devices | #1258314 |
Documents (39)
- 483 · DGI Group LLC · August 19, 2025
- 483 · Artegraft, Inc. · April 16, 2025
- 483 · Fermatex Vascular Technologies · June 24, 2025
- 483 · LeMaitre Vascular, Inc. · October 18, 2023
- 483 · SpaceBander Corporation · May 27, 2025
- 483 · Lingraphicare America, Inc. · February 3, 2025
- 483 · Richmond Diagnostics, Inc. · July 25, 2025
- 483 · Alfa Wassermann, Inc. · September 27, 2022
- 483 · Almark Tool & Manufacturing Company, Inc. · February 7, 2023
- 483 · Howmedica Osteonics Corp. · December 1, 2023
- 483 · Datascope Corp. · June 11, 2018
- 483 · Alkaline Corp. · August 16, 2022
- 483 · Microcision Llc · August 9, 2023
- 483 · UMI Intl · October 20, 2022
- 483 · Enterix, Inc. · March 10, 2023
- 483 · Angel Medical Systems, Inc. · March 28, 2022
- 483 · LifeCell Corporation · June 14, 2019
- 483 · Light Age, Inc. · September 29, 2023
- 483 · Pausch LLC · November 9, 2022
- 483 · Careox, Llc · August 29, 2025
- 483 · Accusync Medical Research Corp · August 15, 2019
- 483 · Light Age, Inc. · July 1, 2022
- 483 · Light Age, Inc. · March 11, 2020
- 483 · Next Medical Products Company, LLC · October 4, 2021
- 483 · Maquet Cardiovascular, LLC · February 26, 2021
- 483 · DEPUY (IRELAND) · December 9, 2016
- 483 · Sterigenics US LLC · May 31, 2023
- 483 · Navinta, LLC · June 29, 2023
- 483 · Aeton Medical · August 9, 2023
- 483 · Quadm Technologies, Llc · April 25, 2022
- 483 · LifeCell Corporation · August 25, 2017
- 483 · Svelte Medical Systems, Inc. · June 14, 2021
- 483 · Datascope Corp. · October 3, 2018
- 483 · Sterigenics UK Limited · September 25, 2025
- 483 · LeMaitre Vascular, Inc. · August 24, 2023
- 483 · IVIMEA LLC · March 31, 2026
- 483 · Artegraft, Inc. · June 25, 2026
- 483 · Accupac, Llc · February 13, 2026
- 483 · Enterix, Inc. · August 10, 2026
Frequently inspected with (10)
Person Information
Name
Frank J. Marciniak
Role
ISSUING OFFICER
ID: 6995351a-6afc-4056-9692-d4aeb711dd92
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