FDA Inspection
Advanced Reproductive Health Centers LTD, Chicago IVFAdvanced Reproductive Health Centers LTD, Chicago IVF – FDA Inspection, Sep 18, 2013
Record Details
This FDA Inspection record concerns Advanced Reproductive Health Centers LTD, Chicago IVF, with an inspection on September 18, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 18, 2013
- Product Type
- Biologics
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ID · 93151ba4-0d11-4e67-912c-51d6ffadcd11
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848340
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
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Other FDA inspections of Advanced Reproductive Health Centers LTD, Chicago IVF
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 5, 2023 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 14, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 22, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 23, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Advanced Reproductive Health Centers LTD, Chicago IVF
- FDA Inspection 1251520 - 2024-09-18
- FDA Inspection 1209490 - 2023-07-05
- FDA Inspection 1050591 - 2018-03-14
- FDA Inspection 969964 - 2016-04-22
- FDA Inspection 880297 - 2014-05-23
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