FDA Inspection 708416 — MegaFood

MegaFood — FEI 3004390513

The FDA completed an inspection of MegaFood on January 25, 2011 in Londonderry, NH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 25, 2011
Fiscal Year
2011
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Londonderry, NH (United States)

Citations

IDCFRDescription
15351FDCA 761(b)(1)No AE report made (dietary supplement)
1554221 CFR 111.260(b)Batch record - date, time; maintenance
1555221 CFR 111.260(j)(2)Batch record - initials; each step
1573721 CFR 111.210(h)(5)Corrective action plans
1574021 CFR 111.210(h)(3)(ii)(A)Instructions; components; weight, measure
1574721 CFR 111.210(g)Packaging description, representative label
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1588521 CFR 111.77(a)Specifications not met - reject, quality control
1592021 CFR 111.95(b)(1)Records - established specifications
1595321 CFR 111.113(a)(1)Quality control production, process control; material review, disposition
1596421 CFR 111.113(c)Document - material review, disposition