FDA Inspection
ARJ Medical, Inc. / Gulf Coast Scientific IncARJ Medical, Inc. / Gulf Coast Scientific Inc – FDA Inspection, Feb 14, 2011
Record Details
This FDA Inspection record concerns ARJ Medical, Inc. / Gulf Coast Scientific Inc, with an inspection on February 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 14, 2011
- Product Type
- Devices
View Company Profile
ID · efc0bd3c-5779-43be-9fb9-ef5d1d183211
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 708908
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of ARJ Medical, Inc. / Gulf Coast Scientific Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2021 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 10, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 19, 2019 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| July 21, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 9, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ARJ Medical, Inc. / Gulf Coast Scientific Inc
- FDA Inspection 1155973 - 2021-10-19
- FDA Inspection 1115249 - 2020-01-10
- FDA Inspection 1089785 - 2019-04-19
- FDA Inspection 935240 - 2015-07-21
- FDA Inspection 756723 - 2011-12-09
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