1115745

Salud Natural Entrepreneur, Inc. — FEI 3008485725

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 22, 2020
Fiscal Year
2020
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Waukegan, IL (United States)

Citations

IDCFRDescription
1550621 CFR 111.27(a)(4)Equipment - bonded seams
1553221 CFR 111.255(b)Batch record - complete
1554521 CFR 111.260(e)Batch record - component; identity, weight
1555021 CFR 111.260(j)Batch record - manufacture
1556321 CFR 111.260(l)(1)(i)Batch record - quality control review; monitoring
1556721 CFR 111.260(l)(4)Batch record - approved, released, rejected
1556821 CFR 111.260(m)Batch record - performance
1564221 CFR 111.455(a)Hold - temperature, humidity, light
1573321 CFR 111.365Manufacturing operations - prevent contamination
1573721 CFR 111.210(h)(5)Corrective action plans
1573921 CFR 111.210(h)(3)(ii)(B)Components; add, verify
1574421 CFR 111.210(h)(2)Master manufacturing record - sampling, tests, examinations
1574521 CFR 111.210(h)(1)Instructions; specifications; packaged, labeled
1574721 CFR 111.210(g)Packaging description, representative label
1574821 CFR 111.210(f)Master manufacturing record theoretical and expected yield
1575021 CFR 111.210(d)Master manufacturing record - ingredients list
1575221 CFR 111.210(c)Master manufacturing record - components; weight, measure
1575321 CFR 111.210(b)Master manufacturing record - list components
1575421 CFR 111.210(a)Master manufacturing record - dietary ingredients
1575921 CFR 111.205(b)(2)Master manufacturing record - controls, procedures
1576221 CFR 111.205(a)Master manufacturing record - each batch
1591921 CFR 111.95(a)Records - production, process control: readily available
1592021 CFR 111.95(b)(1)Records - established specifications
1592721 CFR 111.103Written procedures - quality control operations
1592821 CFR 111.103Written procedure quality control operations material review
1596321 CFR 111.113(b)(2)Quality control - reject; specification not met
1596421 CFR 111.113(c)Document - material review, disposition
1598621 CFR 111.123(b)(2)Quality control - batch, product specifications