Company
United StatesRady Children's Hospital and Health Center, San Diego, CA – FDA Inspections
Inspection records and compliance data for Rady Children's Hospital and Health Center in San Diego, California. 7 FDA inspections on record, last inspected May 28, 2024.
Company Profile
This profile covers Rady Children's Hospital and Health Center based in San Diego, California, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected March 5, 2009. Last inspected May 28, 2024.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs2 inspections
- Procedures not in writing, fully followed1 inspection
- Required records - transfusion reaction and complaints1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 28, 2024 | NAI | Biologics · Blood and Blood Products | 1241097 |
| March 27, 2019 | NAI | Biologics · Blood and Blood Products | 1089274 |
| June 6, 2017 | NAI | Biologics · Blood and Blood Products | 1015488 |
| August 14, 2015 | NAI | Biologics · Blood and Blood Products | 939811 |
| December 7, 2012 | NAI | Biologics · Blood and Blood Products | 809878 |
| June 14, 2011 | VAI | Biologics · Blood and Blood Products | 732743 |
| March 5, 2009 | VAI | Biologics · Blood and Blood Products | 573354 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Rady Children's Hospital and Health Center
FEI Number
2077879
Address
3020 Childrens Way Mc 5007, San Diego, California 92123, United States
Country
United States
ID: 7e86ee1d-617b-4200-a5b5-2ea2edd99223