FDA Inspection
IntegraMed Medical illinois, LLCIntegraMed Medical illinois, LLC – FDA Inspection, Apr 5, 2016
Record Details
This FDA Inspection record concerns IntegraMed Medical illinois, LLC, with an inspection on April 5, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 5, 2016
- Product Type
- Biologics
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ID · 0255dc90-6a38-455c-987e-df9c6d1929da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 968474
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
Other FDA inspections of IntegraMed Medical illinois, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2018 | 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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