FDA Inspection
Genesis Biologics, Inc.Genesis Biologics, Inc. – FDA Inspection, Sep 16, 2026
Record Details
This FDA Inspection record concerns Genesis Biologics, Inc., with an inspection on September 16, 2026, issued by the Los Angeles District Office, covering biologics.
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ID · 216fe61f-5240-4f29-87bf-c510796efc26
Inspection Facts
- Inspection number
- 1336164
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.18(d)(1)Distributor responsibilities for complaint records
- ISO 13485:2016 Clause 7.4.2Purchasing information lacks written agreement regarding notification of changes
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
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Other FDA inspections of Genesis Biologics, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 21, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 26, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 10, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 25, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Genesis Biologics, Inc.
- FDA Inspection 1293426 - 2025-11-20
- FDA Inspection 1210563 - 2023-07-21
- FDA Inspection 1060113 - 2018-06-26
- FDA Inspection 908700 - 2014-12-10
- FDA Inspection 783686 - 2012-05-25
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