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PT. Gunacipta Multirasa — FDA Facility Profile

FEI 3009847830

PT. Gunacipta Multirasa is an FDA-inspected facility (FEI 3009847830) located in Tangerang, ID. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
May 21, 2019: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 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
2

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
May 21, 2019Voluntary Action Indicated (VAI)Quality control procedures (21 CFR 114.80(a))
Container testing (21 CFR 114.80(a)(4))
Code - required elements (21 CFR 114.80(b))
Scheduled process establishment (21 CFR 114.83)
and 2 more
Aug 21, 2015Voluntary Action Indicated (VAI)Work-in-progress (21 CFR 110.80(b)(5))
Equipment, containers, utensils (21 CFR 110.80(b)(7))

Facility details

Company
PT. Gunacipta Multirasa
Location
Tangerang (ID)
Source
inspections

Import refusals

FDA data resources

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