FDA Inspection
Xymogen Manufacturing, LLCXymogen Manufacturing, LLC – FDA Inspection, Aug 13, 2024
Record Details
This FDA Inspection record concerns Xymogen Manufacturing, LLC, with an inspection on August 13, 2024, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 017e67e6-87cc-4975-aa92-a3c65020be70
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1246381
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
8- 21 CFR 111.70(b)Specifications - components
- 21 CFR 111.75(d)(1)Documentation specifications met; exempted, periodic testing
- 21 CFR 111.315(e)Examination, testing; established criteria
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 111.315(d)Standard reference materials; criteria for selecting
- 21 CFR 111.320(b)Examination, testing; scientifically valid
- 21 CFR 111.205(a)Master manufacturing record - prepared
- 21 CFR 111.210Master manufacturing record - record requirements
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Other FDA inspections of Xymogen Manufacturing, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2022 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 16, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 10, 2014 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 24, 2013 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 6, 2012 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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