FDA Inspection
GeneXtend, LLCGeneXtend, LLC – FDA Inspection, Aug 17, 2018
Record Details
This FDA Inspection record concerns GeneXtend, LLC, with an inspection on August 17, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · ddaed345-a1ec-4042-93bf-ad693ec786ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062807
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of GeneXtend, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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