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FDA Inspection
•Morningstar Minerals LLC•November 21, 2019

Morningstar Minerals LLC – FDA Inspection, Nov 21, 2019

Record Details

This FDA Inspection record concerns Morningstar Minerals LLC, with an inspection on November 21, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Morningstar Minerals LLC
Inspection Date
November 21, 2019
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 835b88f4-bcd7-4172-8936-071d29c1178c

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
1110682
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ
Enforcement
Warning Letter

FDA Citations

8
  1. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  2. 21 CFR 111.205(a)Master manufacturing record - each batch
  3. 21 CFR 111.123Quality control operations - master, batch, manufacturing
  4. 21 CFR 111.255(c)Batch record - follow master
  5. 21 CFR 111.260(j)Batch record - manufacture
  6. 21 CFR 111.260(d)Batch record - component; unique identifier
  7. 21 CFR 111.210(g)Packaging description, representative label
  8. 21 CFR 111.123(a)(1)Quality control operations - master manufacturing record, modifications

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Morningstar Minerals LLC

4
DateClassificationOfficeProject area
May 2, 2024Not classifiedDenver District OfficeFood Composition, Standards, Labeling and Econ
January 21, 2022OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 17, 2018OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 23, 2015VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Morningstar Minerals LLC
  • FDA Inspection 1237489 - 2024-05-02
  • FDA Inspection 1161233 - 2022-01-21
  • FDA Inspection 1069208 - 2018-10-17
  • FDA Inspection 960834 - 2015-10-23

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