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, Apr 7, 2023
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 April 7, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 7, 2023
- Product Type
- Biologics
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ID · a563dc16-4530-4f9a-a4f5-e19a306c4397
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1202722
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.55(c)Name and personal info on accompanying records
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 |
| 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 1265185 - 2025-03-28
- 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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