FDA Inspection
Niche Pharmaceuticals, IncNiche Pharmaceuticals, Inc – FDA Inspection, Oct 18, 2016
Record Details
This FDA Inspection record concerns Niche Pharmaceuticals, Inc, with an inspection on October 18, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 5dd896a4-cd9f-4cb2-8c55-ba9d57e93d38
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989066
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.70(e)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.455(a)Hold - temperature, humidity, light
Full citation text and observation details available on the Dashboard.
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 26, 2019 | VAI | 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 |
Other documents for Niche Pharmaceuticals, Inc
- FDA Inspection 1219264 - 2023-08-24
- FDA Inspection 1083925 - 2019-03-26
- FDA Inspection 1045195 - 2018-03-22
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