FDA Inspection 1100179 — The Dragontree Apothecary LLC

The Dragontree Apothecary LLC — FEI 3012213311

The FDA completed an inspection of The Dragontree Apothecary LLC on August 21, 2019 in Boulder, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 21, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Boulder, CO (United States)

Citations

IDCFRDescription
1548021 CFR 111.20(h)Physical plant - screening against pests
1553221 CFR 111.255(b)Batch record - complete
1579721 CFR 111.553Written procedures - product complaint
1581921 CFR 111.55Production, process controls - implement
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1592721 CFR 111.103Written procedures - quality control operations