813399

Evol Nutrition Associates, Inc. — FEI 3008814202

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 4, 2013
Fiscal Year
2013
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Marietta, GA (United States)

Citations

IDCFRDescription
1538821 CFR 111.10(b)Personnel - hygienic practices
1540421 CFR 111.12(c)Personnel - education, training, experience
1542821 CFR 111.15(h)Bathrooms - clean
1554021 CFR 111.260(a)(2)(i)Batch record - control number, each lot
1558321 CFR 111.155(d)(1)Components - identify lot received
1561921 CFR 111.180(b)(1)Written procedures - packaging, labeling received
1567121 CFR 111.315Laboratory control processes - requirements
1571521 CFR 111.375(b)Records - manufacturing operations; written procedures
1576221 CFR 111.205(a)Master manufacturing record - each batch
1578121 CFR 111.415Fill, assemble, package, label - quality
1578321 CFR 111.410(d)Manufacturing history
1579621 CFR 111.430(b)Records - packaging, labeling operations
1580921 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
1582921 CFR 111.70(b)(1)Specifications - component identity
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
1592721 CFR 111.103Written procedures - quality control operations
1593021 CFR 111.105Quality control - ensure quality; package, labeled, master record
1596521 CFR 111.117Quality control operations - equipment, instruments, control
1605721 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
1608721 CFR 111.123(b)(4)Quality control supplier product released assurance not provided package