FDA Inspection
Quillen Fertility And Women's ServicesQuillen Fertility And Women's Services – FDA Inspection, Jan 15, 2014
Record Details
This FDA Inspection record concerns Quillen Fertility And Women's Services, with an inspection on January 15, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 15, 2014
- Product Type
- Biologics
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ID · bf7df152-b1c1-4b9a-bcf0-f5a3c7064357
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 862446
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Quillen Fertility And Women's Services
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 18, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 24, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 20, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 19, 2008 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Quillen Fertility And Women's Services
- FDA Inspection 1221285 - 2023-09-13
- FDA Inspection 1053812 - 2018-04-18
- FDA Inspection 983527 - 2016-08-24
- FDA Inspection 746792 - 2011-09-20
- FDA Inspection 550230 - 2008-11-19
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