FDA Inspection
SigmaGraft IncSigmaGraft Inc – FDA Inspection, Apr 25, 2025
Record Details
This FDA Inspection record concerns SigmaGraft Inc, with an inspection on April 25, 2025, issued by the Los Angeles District Office, covering biologics.
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ID · 703b6ad8-a7f3-4424-848f-9ea6b59b663a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1254544
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.265(e)Procedures and release criteria
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SigmaGraft Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 11, 2014 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 2, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SigmaGraft Inc
- FDA Inspection 1086611 - 2019-03-07
- FDA Inspection 866325 - 2014-02-11
- FDA Inspection 722533 - 2011-05-02
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