FDA Inspection
Sound Fertility Care PLLCSound Fertility Care PLLC – FDA Inspection, Jan 12, 2018
Record Details
This FDA Inspection record concerns Sound Fertility Care PLLC, with an inspection on January 12, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d0a32fcf-907a-4dd0-8c26-bfa7f79560d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037507
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.80(b)Specimen collections not timely
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sound Fertility Care PLLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 6, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Sound Fertility Care PLLC
- FDA Inspection 1117049 - 2020-02-06
- FDA Inspection 969510 - 2016-05-06
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