1120120

Lipo Naturals, LLC — FEI 3010897424

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 9, 2020
Fiscal Year
2020
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Port St Lucie, FL (United States)

Citations

IDCFRDescription
1545321 CFR 111.16Written procedures - cleaning
1549321 CFR 111.25(b)Procedures - calibrating automated, mechanical equip
1549421 CFR 111.25(c)Procedures - equipment - cleaning, sanitizing
1554221 CFR 111.260(b)Batch record - date, time; maintenance
1554321 CFR 111.260(c)Batch record - date, time; maintenance
1554421 CFR 111.260(d)Batch record - component; unique identifier
1554521 CFR 111.260(e)Batch record - component; identity, weight
1554921 CFR 111.260(i)Batch record - specifications
1555221 CFR 111.260(j)(2)Batch record - initials; each step
1555721 CFR 111.260(k)Batch record - packaging, labeling
1556021 CFR 111.260(k)(2)Batch record - label
1556421 CFR 111.260(l)(1)(ii)Batch record - quality control; tests, examinations
1556621 CFR 111.260(l)(3)Batch record - approved, released, rejected; batch
1561921 CFR 111.180(b)(1)Written procedures - packaging, labeling received
1562121 CFR 111.180(b)(1)Written procedures - rejected components, packaging, labels
1565921 CFR 111.475(b)(1)Written procedures - holding; distributing
1571521 CFR 111.375(b)Records - manufacturing operations; written procedures
1576221 CFR 111.205(a)Master manufacturing record - each batch
1579021 CFR 111.403Written procedures - labeling operations
1579621 CFR 111.430(b)Records - packaging, labeling operations
1580921 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
1589721 CFR 111.83(a)Reserve sample - collect, hold
1592721 CFR 111.103Written procedures - quality control operations
1597021 CFR 111.120Quality control operations - components, packaging, labels
1597621 CFR 111.123Quality control operations - master, batch, manufacturing
1605721 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
307821 CFR 114.80(b)Code - required elements
308821 CFR 114.100(b)Processing and production - required information