FDA Inspection
Newport Beach IVF, LLC dba Ovation FertilityNewport Beach IVF, LLC dba Ovation Fertility – FDA Inspection, Feb 26, 2013
Record Details
This FDA Inspection record concerns Newport Beach IVF, LLC dba Ovation Fertility, with an inspection on February 26, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 26, 2013
- Product Type
- Biologics
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ID · ecdbd3bf-26fb-4dc9-bbd4-848b0fd55da9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 819387
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
- 21 CFR 1271.47(a)Procedures for all other requirements
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Other FDA inspections of Newport Beach IVF, LLC dba Ovation Fertility
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 25, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 1, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 29, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Newport Beach IVF, LLC dba Ovation Fertility
- FDA Inspection 1225580 - 2023-12-13
- FDA Inspection 1102784 - 2019-07-25
- FDA Inspection 985378 - 2016-09-01
- FDA Inspection 696941 - 2010-10-29
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