FDA Inspection
The Fertility Partnership, LLCThe Fertility Partnership, LLC – FDA Inspection, Mar 5, 2018
Record Details
This FDA Inspection record concerns The Fertility Partnership, LLC, with an inspection on March 5, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 877be8ba-429b-40e1-82df-bace1cfdcf28
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1043045
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.60(b)Identified as quarantined, distinguishable
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of The Fertility Partnership, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 11, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 26, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 18, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 14, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for The Fertility Partnership, LLC
- FDA Inspection 1224263 - 2023-12-01
- FDA Inspection 1069356 - 2018-10-11
- FDA Inspection 957140 - 2016-01-26
- FDA Inspection 866471 - 2014-02-18
- FDA Inspection 811448 - 2012-12-14
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