FDA Inspection
United Laboratories Manufacturing, LLCUnited Laboratories Manufacturing, LLC – FDA Inspection, Jul 17, 2012
Record Details
This FDA Inspection record concerns United Laboratories Manufacturing, LLC, with an inspection on July 17, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- July 17, 2012
- Product Type
- Food/cosmetics
View Company Profile
ID · e4220373-753a-4665-b522-70857f279779
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 792112
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
8- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.188(b)(12)Documentation of Batch Investigations
- 21 CFR 111.410(b)Packaging - issuance, use
- 21 CFR 111.123(a)(8)Quality control - finished batch, distribution
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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 |
| December 14, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 22, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for United Laboratories Manufacturing, LLC
- FDA Inspection 1064724 - 2018-08-31
- FDA Inspection 1034896 - 2017-12-14
- FDA Inspection 828668 - 2013-04-22
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