PT. Intimas Surya — FDA Facility Profile

FEI 3004254617

PT. Intimas Surya is an FDA-inspected facility (FEI 3004254617) located in Jakarta, ID. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Jul 27, 2017: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
May 25, 2011
Warning letters
1 listed by FDA for this FEI, latest Dec 23, 2011
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
Jul 27, 2017Voluntary Action Indicated (VAI)Sanitation monitoring (21 CFR 123.11(b))
Monitoring record review adequacy (21 CFR 123.8(a)(3)(i))
Verification procedures - none/frequency (21 CFR 123.6(c)(6))
HACCP plan location (21 CFR 123.6(b))
May 25, 2011Official Action Indicated (OAI)Sewage disposal (21 CFR 110.37(c))
Sanitation monitoring (21 CFR 123.11(b))
Monitoring - adequacy (21 CFR 123.6(c)(4))
Critical control points (21 CFR 123.6(c)(2))

Facility details

Company
PT. Intimas Surya
Location
Jakarta (ID)
Source
inspections

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