FDA Person
FDAJames A. Lane
View detailed information about James A. Lane, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 58 inspections of 58 companies, 2016–2019.
Inspections (58)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 25, 2019 | Paragon BioTeck Inc | NAI | Compliance: Devices | #1109013 |
| September 12, 2019 | Medicol USA Inc. | NAI | Postmarket Assurance: Devices | #1102238 |
| August 22, 2019 | Abaxis Inc | VAI | Compliance: Devices | #1100338 |
| August 8, 2019 | Varex Imaging Corporation | VAI | Compliance: Devices | #1099333 |
| July 26, 2019 | Jazz Imaging | VAI | Compliance: Devices | #1097837 |
| June 20, 2019 | NeuroSync, Inc. | NAI | Postmarket Assurance: Devices | #1093677 |
| June 6, 2019 | Minaris Medical America, Inc. | NAI | Compliance: Devices | #1097911 |
| May 7, 2019 | Intuitive Surgical Inc. | NAI | Compliance: Devices | #1093794 |
| April 23, 2019 | Adler MicroMed, Inc. | NAI | Compliance: Devices | #1089915 |
| March 21, 2019 | CIMILRE CO., LTD. | NAI | Compliance: Devices | #1090257 |
| March 13, 2019 | Varian Medical Systems China Co., Ltd. | Not classified | #1099474 | |
| March 7, 2019 | Cosmo Far East Technology Limited | NAI | Compliance: Devices | #1090271 |
| February 21, 2019 | Strata Skin Sciences, Inc. | VAI | Postmarket Assurance: Devices | #1080043 |
| February 7, 2019 | Lusys Laboratories, Inc. | VAI | Compliance: Devices | #1078904 |
| January 11, 2019 | Alere San Diego, Inc. | NAI | Compliance: Devices | #1076303 |
| December 10, 2018 | Grifols Diagnostic Solutions Inc. | NAI | Bioresearch Monitoring | #1076855 |
| December 10, 2018 | Hologic, Inc. | NAI | Bioresearch Monitoring | #1076849 |
| October 25, 2018 | Axis-Shield Diagnostics, Ltd. | NAI | Postmarket Assurance: Devices | #1072250 |
| October 18, 2018 | Forest Laboratories Ireland Limited | Not classified | #1073145 | |
| October 11, 2018 | AstraZeneca AB | VAI | New Drug Evaluation | #1068727 |
Documents (11)
- 483 · Jay Egg · April 12, 2011
- 483 · Gynex Corporation · January 6, 2020
- 483 · Abaxis Inc · August 22, 2019
- 483 · Intuitive Surgical, Inc. · March 6, 2020
- EIR · Paragon BioTeck Inc · September 25, 2019
- 483 · Physio-Control, Inc. · November 26, 2019
- EIR · Thoratec LLC · June 12, 2017
- EIR · Abaxis Inc · August 22, 2019
- 483 · PerkinElmer Medical Imaging · August 8, 2019
- 483 · Microgenics Corporation · December 15, 2016
- 483 · Medicol USA Inc. · September 12, 2019
Frequently inspected with (9)
Person Information
Name
James A. Lane
Title
Investigator
Role
Regulatory Personnel
ID: f6cd3d8d-7de9-45c5-9380-7e0c5de4720e
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