FDA Inspection 828703 — Emerald 3 Enterprises, Inc.

Emerald 3 Enterprises, Inc. — FEI 3003314670

The FDA completed an inspection of Emerald 3 Enterprises, Inc. on Apr 24, 2013 in Camdenton, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Apr 24, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Camdenton, MO (United States)

Citations

IDCFRDescription
191821 CFR 211.166(a)(2)Stability sample storage conditions described
431421 CFR 211.84(d)(2)Reports of Analysis (Components)