Company
United StatesPresbiBio, LLC, Irvine, CA – FDA Inspections
Inspection records and compliance data for PresbiBio, LLC in Irvine, California. 2 FDA inspections on record, 1 Form 483, last inspected March 18, 2019.
Company Profile
This profile covers PresbiBio, LLC based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 28, 2016. Last inspected March 18, 2019.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Design verification - documentation1 inspection
- Documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 18, 2019 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1082994 |
| April 28, 2016 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 970189 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
PresbiBio, LLC
FEI Number
3011262878
Address
8845 Irvine Center Dr Ste 100, Irvine, California 92618, United States
Country
United States
ID: 6661ba21-9de3-4961-ae69-900a5ed1e27f