FDA Inspection
Niche Pharmaceuticals, IncNiche Pharmaceuticals, Inc – FDA Inspection, Mar 26, 2019
Record Details
This FDA Inspection record concerns Niche Pharmaceuticals, Inc, with an inspection on March 26, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 11f39cf5-285b-488d-bb33-5a99d1a00989
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083925
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.535(b)(2)Records - ret"nd dietary supplement: material review, dispos
- 21 CFR 111.535(b)(2)Records - ret'nd dietary supplement: material review, dispos
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Other FDA inspections of Niche Pharmaceuticals, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 22, 2018 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 18, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Niche Pharmaceuticals, Inc
- FDA Inspection 1219264 - 2023-08-24
- FDA Inspection 1045195 - 2018-03-22
- FDA Inspection 989066 - 2016-10-18
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