FDA Inspection 955153 — Heron Botanicals, Inc.

Heron Botanicals, Inc. — FEI 3004756270

The FDA completed an inspection of Heron Botanicals, Inc. on December 4, 2015 in Kingston, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 4, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Kingston, WA (United States)

Citations

IDCFRDescription
1553221 CFR 111.255(b)Batch record - complete
1575921 CFR 111.205(b)(2)Master manufacturing record - controls, procedures
1582821 CFR 111.70(a)Specifications - manufacturing process