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SOFGEN PHARMACEUTICALS LLC — FDA Facility Profile

FEI 3044138844

SOFGEN PHARMACEUTICALS LLC is an FDA-inspected facility (FEI 3044138844) located in Miramar, FL, US. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Dec 11, 2019: Voluntary Action Indicated (VAI)
Inspections on record
4 (4 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

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
Dec 11, 2019Voluntary Action Indicated (VAI)Status of Each Lot Identified (21 CFR 211.80(d))
Oct 18, 2017Voluntary Action Indicated (VAI)No citations listed
Oct 2, 2015Voluntary Action Indicated (VAI)No citations listed
Aug 16, 2013Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
SOFGEN PHARMACEUTICALS LLC
Location
Miramar, FL (US)
Source
inspections

FDA data resources

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