Home / Facilities / 3006397783

PT. MAKMUR JAYA SEJAHTERA FDA Inspection Record

FEI 3006397783 · Inspections, Form 483s, warning letters and import refusals

PT. MAKMUR JAYA SEJAHTERA is an FDA-inspected facility (FEI 3006397783) located in DENPASAR, ID. RegDataLab tracks 1 FDA inspection at this facility.

Reviewing PT. MAKMUR JAYA SEJAHTERA as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check PT. MAKMUR JAYA SEJAHTERA yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

What FDA found at this site

Latest inspection
Oct 7, 2010: 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
Oct 7, 2010Voluntary Action Indicated (VAI)Records values/observations (21 CFR 123.6(c)(7))
Records entries - timing (21 CFR 123.9(a))
Monitoring - none (21 CFR 123.6(c)(2))
Verification procedures - none/frequency (21 CFR 123.6(c)(6))
and 1 more

Facility details

Company
PT. MAKMUR JAYA SEJAHTERA
Location
DENPASAR (ID)
Source
inspections

Import refusals

FDA data resources

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