FDA Inspection
IntegraMed Medical illinois, LLCIntegraMed Medical illinois, LLC – FDA Inspection, Apr 2, 2014
Record Details
This FDA Inspection record concerns IntegraMed Medical illinois, LLC, with an inspection on April 2, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 2, 2014
- Product Type
- Biologics
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ID · cfddf6bd-5a22-4881-adb8-881c7b4c2f52
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 872307
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(c)Name and personal info on accompanying records
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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 5, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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