Company
United StatesBerkeley Advanced Biomaterials, LLC, Berkeley, CA – FDA Inspections
Inspection records and compliance data for Berkeley Advanced Biomaterials, LLC in Berkeley, California. 10 FDA inspections on record, 1 Form 483, last inspected November 22, 2024.
Company Profile
This profile covers Berkeley Advanced Biomaterials, LLC based in Berkeley, California, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 1
- NAI
- 9
- Form 483s
- 1
- Warning letters
- 0
First inspected March 17, 2009. Last inspected November 22, 2024.
Most cited issue areas
- Causing contamination, increasing risks1 inspection
- Monitoring--cross contamination, exposure to CD1 inspection
- Records incomplete1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 22, 2024 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1256931 |
| September 5, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1102665 |
| August 2, 2019 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1105222 |
| June 28, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 978232 |
| April 18, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 983348 |
| July 12, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 839484 |
| April 12, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 827072 |
| February 17, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 712075 |
| December 17, 2010 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 702490 |
| March 17, 2009 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 571463 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Berkeley Advanced Biomaterials, LLC
FEI Number
3014298539
Address
2800 7th St, Berkeley, California 94710, United States
Country
United States
ID: 39f72730-d455-4d24-8dfd-43750ed40672