FDA Inspection
Blue Sky Fertility Services LLCBlue Sky Fertility Services LLC – FDA Inspection, Jun 28, 2018
Record Details
This FDA Inspection record concerns Blue Sky Fertility Services LLC, with an inspection on June 28, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d09ff4ce-da72-4960-b020-0296ae9b554c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1057764
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.47(c)Availability of procedures
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
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Other FDA inspections of Blue Sky Fertility Services LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2025 | Not classified | Kansas City District Office | |
| September 6, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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