Company
United StatesGrifols Diagnostic Solutions Inc., Emeryville, CA – FDA Inspections
Inspection records and compliance data for Grifols Diagnostic Solutions Inc. in Emeryville, California. 12 FDA inspections on record (1 OAI), 3 Form 483s, last inspected October 31, 2025.
Company Profile
This profile covers Grifols Diagnostic Solutions Inc. based in Emeryville, California, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 1
- VAI
- 6
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected July 15, 2010. Last inspected October 31, 2025.
Most cited issue areas
- Investigator statement (FDA 1572)1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 31, 2025 | VAI | Biologics · Blood and Blood Products | 1289592 |
| December 13, 2024 | Not classified | Biologics | 1258104 |
| December 7, 2021 | NAI | Biologics · Vaccines and Allergenic Products | 1162064 |
| February 15, 2019 | VAI | Biologics · Blood and Blood Products | 1079880 |
| September 28, 2016 | VAI | Biologics · Blood and Blood Products | 991586 |
| January 29, 2014 | NAI | Biologics · Blood and Blood Products | 894326 |
| May 10, 2013 | VAI | Human Drugs · Drug Quality Assurance | 830925 |
| May 24, 2012 | OAI | Biologics · Blood and Blood Products | 784225 |
| March 30, 2012 | VAI | Biologics, Medical Devices & Rad Health · Blood and Blood Products | 773744 |
| June 17, 2011 | NAI | Human Drugs · Drug Quality Assurance | 730414 |
| July 16, 2010 | NAI | Human Drugs · Drug Quality Assurance | 672272 |
| July 15, 2010 | VAI | Biologics · Blood and Blood Products | 674393 |
FDA documents
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Company Information
Name
Grifols Diagnostic Solutions Inc.
FEI Number
1000124057
Address
4560 Horton St, Emeryville, California 94608, United States
Country
United States
ID: 367fc2ea-4212-40dc-828b-ea132f3f3206