FDA Inspection
Universal Holdings I LLC dba Smith Brothers CompanyUniversal Holdings I LLC dba Smith Brothers Company – FDA Inspection, Mar 2, 2012
Record Details
This FDA Inspection record concerns Universal Holdings I LLC dba Smith Brothers Company, with an inspection on March 2, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 2, 2012
- Product Type
- Drugs
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ID · c1c08fe7-0ef8-42b1-83ab-f978b445bd9b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769384
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
18- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 110.80(b)(13)Filling, assembling, packing controls
- 21 CFR 110.20(b)(7)Screening
- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
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Other FDA inspections of Universal Holdings I LLC dba Smith Brothers Company
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2014 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| June 11, 2010 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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