FDA Inspection
ARJ Medical, Inc. / Gulf Coast Scientific IncARJ Medical, Inc. / Gulf Coast Scientific Inc – FDA Inspection, Apr 19, 2019
Record Details
This FDA Inspection record concerns ARJ Medical, Inc. / Gulf Coast Scientific Inc, with an inspection on April 19, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 19, 2019
- Product Type
- Devices
View Company Profile
ID · a2a57af6-1ab8-446b-8c30-5f2be2507918
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089785
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
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 |
| 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 |
| February 14, 2011 | OAI | 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 935240 - 2015-07-21
- FDA Inspection 756723 - 2011-12-09
- FDA Inspection 708908 - 2011-02-14
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