FDA Inspection
ARJ Medical, Inc. / Gulf Coast Scientific IncARJ Medical, Inc. / Gulf Coast Scientific Inc – FDA Inspection, Mar 9, 2010
Record Details
This FDA Inspection record concerns ARJ Medical, Inc. / Gulf Coast Scientific Inc, with an inspection on March 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 9, 2010
- Product Type
- Devices
View Company Profile
ID · 79700a54-bf9b-4117-93d5-cb348177dd85
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 650411
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 803.17Lack of Written MDR Procedures
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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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