PT. Super Saku Bali — FDA Facility Profile

FEI 2000043135

PT. Super Saku Bali is an FDA-inspected facility (FEI 2000043135) located in Denpasar, ID. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
May 13, 2016: No Action Indicated (NAI)
Inspections on record
3 (1 OAI, 1 VAI, 1 NAI)
Last OAI inspection
Mar 30, 2012
Warning letters
1 listed by FDA for this FEI, latest Jul 13, 2012
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
May 13, 2016No Action Indicated (NAI)Sanitation monitoring (21 CFR 123.11(b))
Monitoring - adequacy (21 CFR 123.6(c)(4))
HACCP plan implementation (21 CFR 123.6(b))
Critical limits (21 CFR 123.6(c)(3))
Mar 30, 2012Official Action Indicated (OAI)Sanitation monitoring (21 CFR 123.11(b))
Sanitation Records (21 CFR 123.11(c))
Monitoring - adequacy (21 CFR 123.6(c)(4))
Verification procedures - adequacy (21 CFR 123.6(c)(6))
and 5 more
Oct 15, 2010Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
PT. Super Saku Bali
Location
Denpasar (ID)
Source
inspections

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