FDA Inspection
ART Reproductive Center, LLCART Reproductive Center, LLC – FDA Inspection, Mar 23, 2018
Record Details
This FDA Inspection record concerns ART Reproductive Center, LLC, with an inspection on March 23, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · eda20397-93ec-45a3-ad4f-c56614db2380
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045690
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ART Reproductive Center, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 15, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 31, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 3, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 20, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for ART Reproductive Center, LLC
- FDA Inspection 1312612 - 2026-04-14
- FDA Inspection 1178319 - 2022-08-15
- FDA Inspection 983209 - 2016-05-31
- FDA Inspection 839072 - 2013-07-03
- FDA Inspection 732547 - 2011-06-20
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