FDA Inspection
Emerald 3 Enterprises, Inc.Emerald 3 Enterprises, Inc. – FDA Inspection, Apr 19, 2011
Record Details
This FDA Inspection record concerns Emerald 3 Enterprises, Inc., with an inspection on April 19, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Emerald 3 Enterprises, Inc.
- Inspection Date
- April 19, 2011
- Product Type
- Drugs
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ID · 0523577e-9cde-459d-a915-60ba564c1110
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 723214
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
20- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.188(b)(1)Dates not included for each significant step
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.165(c)Sampling and testing plans not described
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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 20, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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