Herbal Extracts Plus, LLC — FDA Facility Profile

FEI 2000010037

Herbal Extracts Plus, LLC is an FDA-inspected facility (FEI 2000010037) located in Bensalem, PA, US. 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 15, 2012: No Action Indicated (NAI)
Inspections on record
2 (1 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest Jan 3, 2012

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 15, 2012No Action Indicated (NAI)No citations listed
Sep 16, 2010Voluntary Action Indicated (VAI)Personnel - records - written procedures (21 CFR 111.14(b)(1))
Physical plant - ventilation, environmental control (21 CFR 111.20(d)(1)(iii))
Equipment - procedures (21 CFR 111.25)
Master manufacturing record - unique formulation (21 CFR 111.205(a))
and 7 more

Facility details

Company
Herbal Extracts Plus, LLC
Location
Bensalem, PA (US)
Source
inspections

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