FDA Inspection
IVF Hawaii, Inc. dba IVF HawaiiIVF Hawaii, Inc. dba IVF Hawaii – FDA Inspection, Aug 14, 2018
Record Details
This FDA Inspection record concerns IVF Hawaii, Inc. dba IVF Hawaii, with an inspection on August 14, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · aaca118c-08b3-4e71-9dd4-4a8631af8bf0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062649
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of IVF Hawaii, Inc. dba IVF Hawaii
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 13, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 15, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for IVF Hawaii, Inc. dba IVF Hawaii
- FDA Inspection 1205573 - 2023-05-02
- FDA Inspection 948461 - 2015-11-13
- FDA Inspection 832139 - 2013-05-15
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