FDA Inspection
UnitDrugCo., LLCUnitDrugCo., LLC – FDA Inspection, Dec 20, 2016
Record Details
This FDA Inspection record concerns UnitDrugCo., LLC, with an inspection on December 20, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · a8cebb23-8c0e-4935-8dd4-42130acb56d7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1004243
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 110.35(d)Failure to clean - general
- 21 CFR 110.10(b)(4)Hand jewelry - remove/cover
- 21 CFR 110.10(b)(6)Failure to wear
- 21 CFR 110.37(e)(2)Hand cleaning and sanitizing preparations
- 21 CFR 110.10(b)(7)Storage of personal items
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.260(f)Batch record - yield
- 21 CFR 111.260(j)(1)Batch record - date, each step
- 21 CFR 111.260(k)(1)Batch record - identifier; labels
Showing 10 of 12 citations.
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Other FDA inspections of UnitDrugCo., LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 12, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 28, 2010 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 15, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for UnitDrugCo., LLC
- FDA Inspection 1107890 - 2019-10-25
- FDA Inspection 857651 - 2013-12-12
- FDA Inspection 696427 - 2010-10-28
- FDA Inspection 621394 - 2009-10-15
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