FDA Inspection
Charleston Area Medical Center, Fertility CenterCharleston Area Medical Center, Fertility Center – FDA Inspection, Apr 16, 2014
Record Details
This FDA Inspection record concerns Charleston Area Medical Center, Fertility Center, with an inspection on April 16, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 16, 2014
- Product Type
- Biologics
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ID · 3c7591f5-12b4-4290-9a81-a7c9857dfbbd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 877242
- 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 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Charleston Area Medical Center, Fertility Center
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 27, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 24, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 30, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 15, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Charleston Area Medical Center, Fertility Center
- FDA Inspection 1223900 - 2023-11-02
- FDA Inspection 1048569 - 2018-02-27
- FDA Inspection 983511 - 2016-08-24
- FDA Inspection 761971 - 2011-12-30
- FDA Inspection 585712 - 2009-05-15
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