Company
United StatesARJ Medical, Inc. / Gulf Coast Scientific Inc, Oldsmar, FL – FDA Inspections
Inspection records and compliance data for ARJ Medical, Inc. / Gulf Coast Scientific Inc in Oldsmar, Florida. 7 FDA inspections on record (2 OAI), last inspected October 19, 2021.
Company Profile
This profile covers ARJ Medical, Inc. / Gulf Coast Scientific Inc based in Oldsmar, Florida, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 2
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected March 9, 2010. Last inspected October 19, 2021.
Most cited issue areas
- Complete files maintained1 inspection
- Design control - no procedures1 inspection
- General1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 19, 2021 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1155973 |
| January 10, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1115249 |
| April 19, 2019 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1089785 |
| July 21, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 935240 |
| December 9, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 756723 |
| February 14, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 708908 |
| March 9, 2010 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 650411 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ARJ Medical, Inc. / Gulf Coast Scientific Inc
FEI Number
3004577174
Address
209 State St E, Oldsmar, Florida 34677, United States
Country
United States
ID: 4ae36548-fe61-4965-a546-4b85f4bafe73