FDA Inspection 989606 — Millenium Natural Manufacturing

Millenium Natural Manufacturing — FEI 3001945290

The FDA completed an inspection of Millenium Natural Manufacturing on September 20, 2016 in Doral, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 20, 2016
Fiscal Year
2016
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Doral, FL (United States)

Citations

IDCFRDescription
1545921 CFR 111.20(d)Physical plant - design and construction
1546221 CFR 111.20(d)(1)(iv)Physical plant - temperature, humidity controls
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
1590221 CFR 111.83(b)(4)Reserve sample - twice the quantity
1595721 CFR 111.113(a)(4)Quality control - calibration; quality; material review, disposition
1597621 CFR 111.123Quality control operations - master, batch, manufacturing
1602221 CFR 111.140(b)(3)(iv)Material review, disposition, follow-up; identification