FDA Inspection
IVF Virginia LLCFDA Inspection 1279765 - IVF Virginia LLC - August 18, 2025
Record Details
This FDA Inspection record concerns IVF Virginia LLC, with an inspection on August 18, 2025, issued by the Baltimore District Office, covering biologics.
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ID · 2c1d4f64-7716-4221-a899-b615e7a73c36
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1279765
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
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Other FDA inspections of IVF Virginia LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 23, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 11, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for IVF Virginia LLC
- FDA Inspection 1190309 - 2022-10-20
- FDA Inspection 1109702 - 2019-10-23
- FDA Inspection 1030559 - 2017-10-11
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