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FDA Inspection
•UnitDrugCo., LLC•December 12, 2013

UnitDrugCo., LLC – FDA Inspection, Dec 12, 2013

Record Details

This FDA Inspection record concerns UnitDrugCo., LLC, with an inspection on December 12, 2013, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
UnitDrugCo., LLC
Inspection Date
December 12, 2013
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 30c6f164-af3f-4984-98d2-7b470fea7746

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
857651
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

8
  1. 21 CFR 111.80(a)Components packaging, labels used
  2. 21 CFR 111.25(a)Procedures - calibrating instruments
  3. 21 CFR 111.535(b)(2)Records - ret"nd dietary supplement: material review, dispos
  4. 21 CFR 111.255(b)Batch record - complete
  5. 21 CFR 111.210(g)Packaging description, representative label
  6. 21 CFR 111.120(b)Quality control operations - specifications; components, packaging, labels
  7. 21 CFR 111.123(a)(2)Quality control operations - batch production records
  8. 21 CFR 111.113(a)(2)Quality control master manufacturing record; material review, disposition

Full citation text and observation details available on the Dashboard.

Other FDA inspections of UnitDrugCo., LLC

4
DateClassificationOfficeProject area
October 25, 2019VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
December 20, 2016OAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
October 28, 2010VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 15, 2009NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for UnitDrugCo., LLC
  • FDA Inspection 1107890 - 2019-10-25
  • FDA Inspection 1004243 - 2016-12-20
  • FDA Inspection 696427 - 2010-10-28
  • FDA Inspection 621394 - 2009-10-15

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