PD. Setia Makmur Mandiri — FDA Facility Profile

FEI 3011144101

PD. Setia Makmur Mandiri is an FDA-inspected facility (FEI 3011144101) located in Jakarta Timur, ID. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Aug 26, 2015: 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
1

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
Aug 26, 2015Voluntary Action Indicated (VAI)Materials and workmanship (21 CFR 110.40(a))
Lack of effective pest exclusion (21 CFR 110.35(c))
Equipment, containers, utensils (21 CFR 110.80(b)(7))
Suitable locations (21 CFR 110.37(e)(1))

Facility details

Company
PD. Setia Makmur Mandiri
Location
Jakarta Timur (ID)
Source
inspections

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