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FDA Inspection
•Niche Pharmaceuticals, Inc•March 22, 2018

Niche Pharmaceuticals, Inc – FDA Inspection, Mar 22, 2018

Record Details

This FDA Inspection record concerns Niche Pharmaceuticals, Inc, with an inspection on March 22, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Niche Pharmaceuticals, Inc
Inspection Date
March 22, 2018
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
Person
  • Dana M. Lewis
View Company Profile

ID · 277268e5-b473-423f-a9a0-b6c88bbbce52

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1045195
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 111.453Written procedures - holding
  2. 21 CFR 111.70(e)Specifications - contamination limits
  3. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Niche Pharmaceuticals, Inc

3
DateClassificationOfficeProject area
August 24, 2023NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
March 26, 2019VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 18, 2016VAICenter for Food Safety and Applied NutritionFood 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 989066 - 2016-10-18

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