FDA Inspection 1057760 — Enterprise Mac, LLC

Enterprise Mac, LLC — FEI 3010804175

The FDA completed an inspection of Enterprise Mac, LLC on Jul 3, 2018 in Atlanta, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jul 3, 2018
Fiscal Year
2018
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Atlanta, GA (United States)

Citations

IDCFRDescription
1553221 CFR 111.255(b)Batch record - complete
1575921 CFR 111.205(b)(2)Master manufacturing record - controls, procedures
1582821 CFR 111.70(a)Specifications - manufacturing process
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
1587121 CFR 111.75(c)(2)Specifications met - test, examinations; compliance

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.