FDA Inspection
Columbia Fertility Associates, LLCColumbia Fertility Associates, LLC – FDA Inspection, Apr 16, 2013
Record Details
This FDA Inspection record concerns Columbia Fertility Associates, LLC, with an inspection on April 16, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 16, 2013
- Product Type
- Biologics
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ID · 61455789-99fa-47b4-9c65-4ed42cc2f0be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 827487
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Columbia Fertility Associates, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 22, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 27, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 5, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 21, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Columbia Fertility Associates, LLC
- FDA Inspection 1223899 - 2023-11-14
- FDA Inspection 1110104 - 2019-10-22
- FDA Inspection 1028674 - 2017-09-27
- FDA Inspection 908894 - 2015-01-05
- FDA Inspection 707483 - 2011-01-21
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