Company
United StatesCliniSys, Inc, Tucson, AZ – FDA Inspections
Inspection records and compliance data for CliniSys, Inc in Tucson, Arizona. 4 FDA inspections on record, last inspected July 27, 2023.
Company Profile
This profile covers CliniSys, Inc based in Tucson, Arizona, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected November 14, 2008. Last inspected July 27, 2023.
Most cited issue areas
- Changes to correct/prevent quality problems1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
- Management review - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 27, 2023 | NAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 1215144 |
| February 26, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 915421 |
| July 15, 2011 | NAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 735003 |
| November 14, 2008 | VAI | Biologics, Medical Devices & Rad Health · Blood and Blood Products | 550852 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
CliniSys, Inc
FEI Number
1000306472
Address
3300 E Sunrise Dr, Tucson, Arizona 85718, United States
Country
United States
ID: 0252628f-8127-44c5-b74f-b0605fa1f158