FDA Person
Office of the CommissionerJoseph R. Strelnik
View detailed information about Joseph R. Strelnik, including compliance records, violations, and related data.
Person Profile
FDA investigator, Office of the Commissioner. Took part in 28 inspections of 28 companies, 2016–2019.
Inspections (28)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| June 27, 2019 | Christoph Miethke GmbH & Co. KG | Not classified | Compliance: Devices | #1097330 |
| June 21, 2019 | Belimed D.O.O. | VAI | Compliance: Devices | #1094102 |
| June 19, 2019 | Belimed AG | NAI | Compliance: Devices | #1101394 |
| May 6, 2019 | EHOB, Inc. | VAI | Compliance: Devices | #1089893 |
| April 9, 2019 | Paragon Medical, a division of NN Inc. | NAI | Compliance: Devices | #1092869 |
| October 25, 2018 | Archtek Dental, LLC | NAI | Postmarket Assurance: Devices | #1072029 |
| August 2, 2018 | Fukuda Denshi Co., Ltd. | NAI | Compliance: Devices | #1069224 |
| July 26, 2018 | Anzai Medical Co., Ltd. | NAI | Compliance: Devices | #1069144 |
| July 19, 2018 | Shenzhen Zifound Infonet Technology Co., Ltd. | OAI | Compliance: Devices | #1063881 |
| June 8, 2018 | Biomedix Wai | VAI | Compliance: Devices | #1056265 |
| May 23, 2018 | Avalign Delivery Systems Division | VAI | Compliance: Devices | #1053732 |
| April 27, 2018 | Nexxt Spine, LLC | VAI | Compliance: Devices | #1053731 |
| February 9, 2018 | Chilecom Medical Devices Co. Ltd. | Not classified | Postmarket Assurance: Devices | #1044744 |
| February 1, 2018 | Hanmi Pharma Co., Ltd | NAI | Postmarket Assurance: Devices | #1044743 |
| January 26, 2018 | Terumo Clinical Supply Co. Ltd. | Not classified | Compliance: Devices | #1044742 |
| January 18, 2018 | IBL Acquisitions LLC | Not classified | Radiation Control and Health Safety Act | #1038078 |
| December 6, 2017 | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC | VAI | Compliance: Devices | #1035368 |
| October 16, 2017 | Zimmer, Inc. | VAI | Compliance: Devices | #1029453 |
| September 13, 2017 | Kimball Electronics - Indianapolis | VAI | Postmarket Assurance: Devices | #1025861 |
| August 11, 2017 | Century Pharmaceuticals, Inc. | NAI | Compliance: Devices | #1032039 |
Documents (17)
- 483 · Biomet, Inc. · October 16, 2017
- 483 · Hill-Rom Inc · January 11, 2013
- 483 · Biomet, Inc. · November 22, 2016
- 483 · Unknown Company · April 29, 2011
- 483 · Jay Egg · April 12, 2011
- 483 · Indiana University Hospital · February 3, 2016
- 483 RESPONSE · Biomet, Inc. · November 22, 2016
- 483 · Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. · December 21, 2019
- 483 · Cook Incorporated · September 14, 2021
- 483 · EHOB, Inc. · May 6, 2019
- 483 · Hanmi Pharma Co., Ltd · February 1, 2018
- 483 · Therametric Technologies, Inc. · September 11, 2014
- 483 · ContainMed, Inc. · February 19, 2020
- 483 · Med-Mizer, Inc. · August 6, 2021
- 483 · Hill-Rom Inc · November 19, 2021
- 483 · Kimball Electronics - Indianapolis · February 24, 2022
- 483 · Biomedix Wai · October 31, 2019
Frequently inspected with (4)
Related Office
Person Information
Name
Joseph R. Strelnik
Title
Investigator
Role
Regulatory Personnel
ID: 1fb7d50e-abf2-45ef-85a8-71c61b33e42d
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