FDA Inspection 853958 — American Naturavit Inc.

American Naturavit Inc. — FEI 1000197992

The FDA completed an inspection of American Naturavit Inc. on November 1, 2013 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 1, 2013
Fiscal Year
2014
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Miami, FL (United States)

Citations

IDCFRDescription
1565921 CFR 111.475(b)(1)Written procedures - holding; distributing
1580921 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
1601421 CFR 111.140(b)(1)QC ops; written procedures; material review, disposition
1605721 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures