FDA Inspection
Emerald 3 Enterprises, Inc.Emerald 3 Enterprises, Inc. – FDA Inspection, Apr 20, 2012
Record Details
This FDA Inspection record concerns Emerald 3 Enterprises, Inc., with an inspection on April 20, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Emerald 3 Enterprises, Inc.
- Inspection Date
- April 20, 2012
- Product Type
- Drugs
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ID · 1ec399c7-9a1e-4cef-9420-959e49f43eb8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 778480
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.188(b)(1)Dates not included for each significant step
- 21 CFR 211.111Deviations of production time limits
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Emerald 3 Enterprises, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 19, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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