FDA Inspection 966085 — Science Based Brands, LLC

Science Based Brands, LLC — FEI 3008848273

The FDA completed an inspection of Science Based Brands, LLC on March 29, 2016 in Powell, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 29, 2016
Fiscal Year
2016
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Powell, OH (United States)

Citations

IDCFRDescription
1540921 CFR 111.14(b)(1)Personnel - records - written procedures
1545321 CFR 111.16Written procedures - cleaning
1549121 CFR 111.25Equipment - procedures
1553221 CFR 111.255(b)Batch record - complete
1580921 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
1581921 CFR 111.55Production, process controls - implement
1583821 CFR 111.70(d)Specifications - labels, packaging
1584121 CFR 111.70(f)Specifications - product received for packaging, labeling
1592721 CFR 111.103Written procedures - quality control operations
1605721 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures