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, Mar 28, 2025
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 March 28, 2025, issued by the New York District Office, covering biologics.
- Inspection Date
- March 28, 2025
- Product Type
- Biologics
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ID · ee31dee3-0ff3-4e03-816d-71f2654125dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1265185
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
1- 21 CFR 1271.90(c)Eligibility not required--warning labels
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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 |
|---|---|---|---|
| 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 |
| December 10, 2013 | 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 1202722 - 2023-04-07
- FDA Inspection 1114054 - 2019-11-18
- FDA Inspection 1030817 - 2017-10-10
- FDA Inspection 952439 - 2015-12-10
- FDA Inspection 858296 - 2013-12-10
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