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FDA Inspection
•Emerald 3 Enterprises, Inc.•April 24, 2013

Emerald 3 Enterprises, Inc. – FDA Inspection, Apr 24, 2013

Record Details

This FDA Inspection record concerns Emerald 3 Enterprises, Inc., with an inspection on April 24, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Emerald 3 Enterprises, Inc.
Inspection Date
April 24, 2013
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 4c05f5b7-49aa-45aa-af91-aecc190d6f0a

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
828703
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

2
  1. 21 CFR 211.84(d)(2)Reports of Analysis (Components)
  2. 21 CFR 211.166(a)(2)Stability sample storage conditions described

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Emerald 3 Enterprises, Inc.

2
DateClassificationOfficeProject area
April 20, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 19, 2011VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Emerald 3 Enterprises, Inc.
  • FDA Inspection 778480 - 2012-04-20
  • FDA Inspection 723214 - 2011-04-19

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Contact
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Scranton Office:
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