1061594

Four Elements Organic Herbals, LLC — FEI 3001452409

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 9, 2018
Fiscal Year
2018
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
North Freedom, WI (United States)

Citations

IDCFRDescription
121 CFR 11Electronic records
100521 CFR 110.10(b)(7)Storage of personal items
155221 CFR 110.35(a)Buildings/sanitary
1553221 CFR 111.255(b)Batch record - complete
1557821 CFR 111.155(c)Components - quarantine
1558921 CFR 111.160(c)Packaging, labels - quarantine
1564121 CFR 111.453Written procedures - holding
1566221 CFR 111.303Written procedures - laboratory operations
1573621 CFR 111.353Manufacturing operations - written procedures
1576321 CFR 111.205(a)Master manufacturing record - unique formulation
1579121 CFR 111.403Written procedures -packaging operations
1579721 CFR 111.553Written procedures - product complaint
1582521 CFR 111.65Quality control - quality, dietary supplement
1582921 CFR 111.70(b)(1)Specifications - component identity
1583021 CFR 111.70(b)(2)Specifications-component purity, strength, composition
1583121 CFR 111.70(b)(3)Specifications - contamination limits
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
1589721 CFR 111.83(a)Reserve sample - collect, hold
160121 CFR 110.37(a)Safe and adequate sanitary quality
1605721 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
1606521 CFR 111.35(b)(1)Written procedures - equipment, utensils; make, keep
16494FDCA 601(c)Insanitary conditions; contaminated with filth
168921 CFR 110.80Reasonable precautions
239221 CFR 110.80(b)(1)Maintenance of equip., utensils, and finished food packaging
364721 CFR 110.10(c)Training of handlers and supervisors
365721 CFR 110.37(d)(4)Doors opening into processing areas
366021 CFR 110.37(e)(4)Devices and fixtures