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IMPROVA HERBAL PRODUCTS — FDA Facility Profile

FEI 3013295623

IMPROVA HERBAL PRODUCTS is an FDA-inspected facility (FEI 3013295623) located in Ambethan, IN. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Jun 19, 2018: No Action Indicated (NAI)
Inspections on record
2 (1 OAI, 1 NAI)
Last OAI inspection
Sep 15, 2015
Warning letters
1 listed by FDA for this FEI, latest Dec 15, 2015
Import refusals
6

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jun 19, 2018No Action Indicated (NAI)Code - required elements (21 CFR 114.80(b))
Maintenance of processing and production records (21 CFR 114.100(b))
Recall procedures (21 CFR 108.25(e))
Sep 15, 2015Official Action Indicated (OAI)Personnel (21 CFR 114.10)
Scheduled process establishment (21 CFR 114.83)

Facility details

Company
IMPROVA HERBAL PRODUCTS
Location
Ambethan (IN)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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