FDA Inspection
Gemini Pharmaceuticals, Inc.Gemini Pharmaceuticals, Inc. – FDA Inspection, May 15, 2026
Record Details
This FDA Inspection record concerns Gemini Pharmaceuticals, Inc., with an inspection on May 15, 2026, issued by the New York District Office, covering foods & cosmetics.
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ID · 3c2276f9-a20a-4803-a2e7-9277b1bf2a74
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1317530
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 111.260Batch record - required information
- 21 CFR 111.315(b)Sampling plans; establish, follow
- 21 CFR 111.315(d)Standard reference materials; criteria for selecting
- 21 CFR 111.70(b)Specifications - components
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.75(d)(1)Documentation specifications met; exempted, periodic testing
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Other FDA inspections of Gemini Pharmaceuticals, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2022 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 23, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 16, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 8, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Gemini Pharmaceuticals, Inc.
- FDA Inspection 1175407 - 2022-07-26
- FDA Inspection 1064447 - 2018-08-23
- FDA Inspection 1041525 - 2018-02-16
- FDA Inspection 936886 - 2015-06-30
- FDA Inspection 856101 - 2013-11-08
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