1090817

Life Rising Corporation — FEI 1000139959

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 17, 2019
Fiscal Year
2019
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Willowbrook, IL (United States)

Citations

IDCFRDescription
1541021 CFR 111.14(b)(2)Personnel - records - training
1542921 CFR 111.15(k)Sanitation supervisors - assigned
1545421 CFR 111.16Written procedures - pest control
1549421 CFR 111.25(c)Procedures - equipment - cleaning, sanitizing
1551121 CFR 111.27(d)Equipment - maintain - general
1553121 CFR 111.255(a)Batch record - every batch
1553221 CFR 111.255(b)Batch record - complete
1556121 CFR 111.260(k)(3)Batch record - tests, examinations; results
1573721 CFR 111.210(h)(5)Corrective action plans
1574721 CFR 111.210(g)Packaging description, representative label
1574821 CFR 111.210(f)Master manufacturing record theoretical and expected yield
1575221 CFR 111.210(c)Master manufacturing record - components; weight, measure
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
1576721 CFR 111.425Quarantine - rejected packaged, labeled dietary supplement
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
1586321 CFR 111.75(a)(2)(ii)(B)Component - certificate of analysis
1586521 CFR 111.75(a)(2)(ii)(D)Re-confirm certificate of analysis
1586921 CFR 111.75(c)Specifications met - verify; finished batch
1589721 CFR 111.83(a)Reserve sample - collect, hold
1592721 CFR 111.103Written procedures - quality control operations
1594321 CFR 111.105(i)QC required operations components packaging labels
1596021 CFR 111.113(b)(1)Quality control - dietary supplement; adulteration
1603721 CFR 111.605Records - keep: 1 year, 2 years
1607221 CFR 111.35(b)(3)Instruments, controls; calibrate date, reference std, method