FDA Inspection
SigmaGraft IncSigmaGraft Inc – FDA Inspection, Feb 11, 2014
Record Details
This FDA Inspection record concerns SigmaGraft Inc, with an inspection on February 11, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SigmaGraft Inc
- Inspection Date
- February 11, 2014
- Product Type
- Devices
View Company Profile
ID · 37b1df0a-aaa5-41bf-84ea-4e0ac5194433
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 866325
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 812.150(b)(10)No sponsor report in response to a request
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SigmaGraft Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2025 | VAI | Los Angeles District Office | Human Cellular, Tissue, and Gene Therapies |
| March 7, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 2, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SigmaGraft Inc
- FDA Inspection 1254544 - 2025-04-25
- FDA Inspection 1086611 - 2019-03-07
- FDA Inspection 722533 - 2011-05-02
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