Company
United StatesBerkeley Biologics LLC, Richmond, CA – FDA Inspections
Inspection records and compliance data for Berkeley Biologics LLC in Richmond, California. 6 FDA inspections on record (1 OAI), 2 Form 483s, last inspected April 29, 2026.
Company Profile
This profile covers Berkeley Biologics LLC based in Richmond, California, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 1
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected February 17, 2012. Last inspected April 29, 2026.
Most cited issue areas
- Design of procedures to ensure compliance2 inspections
- Donors with risks not determined ineligible2 inspections
- Validation & approval--established procedures2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 29, 2026 | Not classified | Biologics · Human Cellular, Tissue, and Gene Therapies | 1314676 |
| September 25, 2023 | OAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1218588 |
| June 25, 2021 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1145973 |
| August 28, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1067125 |
| March 25, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 967555 |
| February 17, 2012 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 765182 |
FDA documents
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Berkeley Biologics LLC
FEI Number
1000100754
Address
880 Harbour Way S Ste 100, Richmond, California 94804, United States
Country
United States
ID: a6e5270d-1ca1-40d3-830d-422cf9cb6f58