Company
United StatesSigmaGraft Inc, Fullerton, CA – FDA Inspections
Inspection records and compliance data for SigmaGraft Inc in Fullerton, California. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 25, 2025.
Company Profile
This profile covers SigmaGraft Inc based in Fullerton, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 2, 2011. Last inspected April 25, 2025.
Most cited issue areas
- No sponsor report in response to a request1 inspection
- Procedures and release criteria1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 25, 2025 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1254544 |
| March 7, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1086611 |
| February 11, 2014 | OAI | Medical Devices & Rad Health · Bioresearch Monitoring | 866325 |
| May 2, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 722533 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SigmaGraft Inc
FEI Number
3009598981
Address
575 Sally Pl, Fullerton, California 92831, United States
Country
United States
ID: 4a1f2860-52f0-475a-ad24-b89f3b73a921