FDA Inspection
Gemini Pharmaceuticals, Inc.Gemini Pharmaceuticals, Inc. – FDA Inspection, Feb 16, 2018
Record Details
This FDA Inspection record concerns Gemini Pharmaceuticals, Inc., with an inspection on February 16, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5f815dde-5720-44ae-a6e5-ab350f64a85e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041525
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.80(a)Written Procedures Not Followed
- 21 CFR 211.122(a)Written procedures not followed
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Other FDA inspections of Gemini Pharmaceuticals, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2026 | VAI | New York District Office | Food Composition, Standards, Labeling and Econ |
| 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 |
| 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 1317530 - 2026-05-15
- FDA Inspection 1175407 - 2022-07-26
- FDA Inspection 1064447 - 2018-08-23
- FDA Inspection 936886 - 2015-06-30
- FDA Inspection 856101 - 2013-11-08
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