FDA Inspection 1229269 — Eden's Answers Inc

Eden's Answers Inc — FEI 3012343370

The FDA completed an inspection of Eden's Answers Inc on Feb 9, 2024 in Holmesville, OH. 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). 5 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Feb 9, 2024
Fiscal Year
2024
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Holmesville, OH (United States)

Citations

IDCFRDescription
1576221 CFR 111.205(a)Master manufacturing record - each batch
1583021 CFR 111.70(b)(2)Specifications-component purity, strength, composition
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1600121 CFR 111.130(a)Quality control returned dietary supplement; material review, disposition
1601721 CFR 111.140(b)(3)Records - material review, disposition documentation

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