FDA Inspection
New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.CNew York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C – FDA Inspection, Dec 10, 2013
Record Details
This FDA Inspection record concerns New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C, with an inspection on December 10, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 10, 2013
- Product Type
- Biologics
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ID · 257b2b5e-ae9d-4106-b341-a7b9946fe225
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 858296
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
Other FDA inspections of New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2025 | VAI | New York District Office | Human Cellular, Tissue, and Gene Therapies |
| April 7, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| November 18, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 10, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 10, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C
- FDA Inspection 1265185 - 2025-03-28
- FDA Inspection 1202722 - 2023-04-07
- FDA Inspection 1114054 - 2019-11-18
- FDA Inspection 1030817 - 2017-10-10
- FDA Inspection 952439 - 2015-12-10
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