FDA Inspection
Foulk Nevada Fertility Center, PCFoulk Nevada Fertility Center, PC – FDA Inspection, Feb 1, 2018
Record Details
This FDA Inspection record concerns Foulk Nevada Fertility Center, PC, with an inspection on February 1, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · efb83538-1adc-4092-a0ff-5fa1186ef20e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040654
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.60(c)(2)Records stating determination not completed
- 21 CFR 1271.60(c)(3)Statement of restrictions
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.55(a)(1)Personal information included in I.D. code
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
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Other FDA inspections of Foulk Nevada Fertility Center, PC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 31, 2020 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 8, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 19, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 25, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Foulk Nevada Fertility Center, PC
- FDA Inspection 1236180 - 2024-04-11
- FDA Inspection 1116752 - 2020-01-31
- FDA Inspection 1078892 - 2019-02-08
- FDA Inspection 970558 - 2016-05-19
- FDA Inspection 838595 - 2013-06-25
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