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Wirontono Baru Balaraja — FDA Facility Profile

FEI 3012971946

Wirontono Baru Balaraja is an FDA-inspected facility (FEI 3012971946) located in Tangerang, ID. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Jun 23, 2023: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 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
Import refusals
10 or more

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 23, 2023Voluntary Action Indicated (VAI)Sanitation monitoring (21 CFR 123.11(b))

Facility details

Company
Wirontono Baru Balaraja
Location
Tangerang (ID)
Source
inspections

Import refusals

FDA data resources

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