FDA Inspection
United Laboratories Manufacturing, LLCUnited Laboratories Manufacturing, LLC – FDA Inspection, Apr 22, 2013
Record Details
This FDA Inspection record concerns United Laboratories Manufacturing, LLC, with an inspection on April 22, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 22, 2013
- Product Type
- Drugs
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ID · cb656c8f-059c-4e39-a031-241a3dfc8150
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 828668
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.160(d)(1)Packaging - identify
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.127Quality control operations - packaging, labeling
- 21 CFR 111.123Quality control operations - master, batch, manufacturing
- 21 CFR 111.255(b)Batch record - complete
Showing 10 of 11 citations.
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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 |
| 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 1034896 - 2017-12-14
- FDA Inspection 792112 - 2012-07-17
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