FDA Inspection
AssureImmune, LLCAssureImmune, LLC – FDA Inspection, Jun 16, 2009
Record Details
This FDA Inspection record concerns AssureImmune, LLC, with an inspection on June 16, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- AssureImmune, LLC
- Inspection Date
- June 16, 2009
- Product Type
- Biologics
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ID · d412f139-532b-423e-a63a-e93d9303dba0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 590674
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 1271.85(b)(1)Cell-associated CD
- 21 CFR 1271.250(a)Controlling the labeling of HCT/Ps
- 21 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
- 21 CFR 1271.160(b)(2)Procedures for complaints and other information
Full citation text and observation details available on the Dashboard.
Other FDA inspections of AssureImmune, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 15, 2026 | Not classified | Florida District Office | |
| February 12, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 8, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 16, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for AssureImmune, LLC
- FDA Inspection 1299120 - 2026-01-15
- FDA Inspection 1121360 - 2020-02-12
- FDA Inspection 1034907 - 2017-11-08
- FDA Inspection 842553 - 2013-07-16
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