Pt. Kelola Mina Laut- Integrated Seafood Industries FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection NAI · Jun 23, 2023
  • No warning letters matched by name
Inspections 4 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Pt. Kelola Mina Laut- Integrated Seafood Industries has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Pt. Kelola Mina Laut- Integrated Seafood Industries" is on file.

What these totals cover: FDA records filed under the name "Pt. Kelola Mina Laut- Integrated Seafood Industries".

Latest inspection
Jun 23, 2023 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Pt. Kelola Mina Laut- Integrated Seafood Industries's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Pt. Kelola Mina Laut- Integrated Seafood Industries: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202200000
202100000
202000000
201900000
201810000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

4 inspections from Oct 12, 2010 to Jun 23, 2023.

DateSiteProductClassificationFEI
Jun 23, 2023Gresik, IndonesiaFood/CosmeticsNo Action Indicated (NAI)3003196718
Sep 7, 2018Gresik, IndonesiaFood/CosmeticsVoluntary Action Indicated (VAI)3003196718
Feb 28, 2012Gresik, IndonesiaFood/CosmeticsVoluntary Action Indicated (VAI)3003196718
Oct 12, 2010Gresik, IndonesiaFood/CosmeticsVoluntary Action Indicated (VAI)3003196718
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003196718Gresik, Indonesia4Jun 23, 2023

Pt. Kelola Mina Laut- Integrated Seafood Industries and the FDA: common questions

Has Pt. Kelola Mina Laut- Integrated Seafood Industries received an FDA warning letter?

No FDA warning letter addressed to the name "Pt. Kelola Mina Laut- Integrated Seafood Industries" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Pt. Kelola Mina Laut- Integrated Seafood Industries received an FDA Form 483?

FDA has not published a Form 483 for "Pt. Kelola Mina Laut- Integrated Seafood Industries" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Pt. Kelola Mina Laut- Integrated Seafood Industries?

The most recent FDA inspection on file ended Jun 23, 2023 at Gresik, Indonesia and was classified NAI. FDA has 4 inspections of Pt. Kelola Mina Laut- Integrated Seafood Industries on file.

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