FDA Inspection
United Laboratories Manufacturing, LLCUnited Laboratories Manufacturing, LLC – FDA Inspection, Dec 14, 2017
Record Details
This FDA Inspection record concerns United Laboratories Manufacturing, LLC, with an inspection on December 14, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4b30dfdf-c913-4242-bc63-a804d73694d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034896
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of United Laboratories Manufacturing, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2018 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| April 22, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 17, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for United Laboratories Manufacturing, LLC
- FDA Inspection 1064724 - 2018-08-31
- FDA Inspection 828668 - 2013-04-22
- FDA Inspection 792112 - 2012-07-17
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