FDA Person
FDAScott K. Zika
View detailed information about Scott K. Zika, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 14 inspections of 14 companies, 2017–2018.
Inspections (14)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| August 2, 2018 | Total Thermal Imaging, Inc. | OAI | Compliance: Devices | #1061722 |
| May 21, 2018 | Philips Respironics, Inc. | OAI | Postmarket Assurance: Devices | #1056962 |
| February 15, 2018 | Innovative Medical Manufacturing Co. | Not classified | #1045843 | |
| February 9, 2018 | APEX (GUANGZHOU) TOOLS & ORTHOPEDICS COMPANY | Not classified | #1044843 | |
| November 13, 2017 | Nuance Medical, LLC | NAI | Postmarket Assurance: Devices | #1031624 |
| October 31, 2017 | Sendx Medical Inc | VAI | Compliance: Devices | #1031157 |
| September 29, 2017 | Tandem Diabetes Care, INC. | VAI | Postmarket Assurance: Devices | #1029411 |
| July 31, 2017 | Bioserv Corporation | VAI | Compliance: Devices | #1022355 |
| May 25, 2017 | Baxter Healthcare S.A. | Not classified | #1020825 | |
| May 18, 2017 | COLUMBIA PLASTICS LTD. | Not classified | #1016977 | |
| May 11, 2017 | Thermotex Therapy Systems Ltd | Not classified | #1014372 | |
| April 10, 2017 | Quidel Corporation | NAI | Postmarket Assurance: Devices | #1010641 |
| March 6, 2017 | Invivoscribe Technologies, Inc. | NAI | Postmarket Assurance: Devices | #1006006 |
| February 3, 2017 | Mardx Diagnostics Inc | NAI | Postmarket Assurance: Devices | #1002306 |
Documents (3)
- 483 · Tandem Diabetes Care, Inc. · December 23, 2014
- 483 · Alphatec Spine, Inc. · February 11, 2010
- 483 · Alphatec Spine, Inc. · March 13, 2015
Frequently inspected with (3)
Person Information
Name
Scott K. Zika
Role
ISSUING OFFICER
ID: 7f967edd-5151-438b-a0e7-dd1db8a227d1
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