FDA Inspection
Sound Fertility Care PLLCSound Fertility Care PLLC – FDA Inspection, May 6, 2016
Record Details
This FDA Inspection record concerns Sound Fertility Care PLLC, with an inspection on May 6, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Sound Fertility Care PLLC
- Inspection Date
- May 6, 2016
- Product Type
- Biologics
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ID · bc8af086-894a-4cf5-8b9b-803b4dde7a1c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 969510
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.47(a)Procedures for all other requirements
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 |
| January 12, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Sound Fertility Care PLLC
- FDA Inspection 1117049 - 2020-02-06
- FDA Inspection 1037507 - 2018-01-12
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