FDA Inspection
IntegraMed Medical illinois, LLCIntegraMed Medical illinois, LLC – FDA Inspection, Aug 3, 2018
Record Details
This FDA Inspection record concerns IntegraMed Medical illinois, LLC, with an inspection on August 3, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · debaaf2d-2e18-454a-bba2-7541f0f74a50
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060932
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of IntegraMed Medical illinois, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 2, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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