Has FDA refused shipments from PT Kelola Biru H?

Yes. FDA refused 35 shipment lines from PT Kelola Biru H between November 30, 2018 and April 28, 2023. The most recent, on April 28, 2023, was kingfish (only menticirrhus spp), charged as LIST INGRE (ingredients not listed).

Why did FDA refuse PT Kelola Biru H's shipments?

The most frequent charges are FILTHY (filthy, putrid or decomposed substance, 19 lines) and SALMONELLA (salmonella, 11 lines).

When was PT Kelola Biru H last inspected by FDA?

FDA's most recent inspection of PT Kelola Biru H with a final classification is dated May 15, 2018 and was classified NAI (No Action Indicated).

What is PT Kelola Biru H's FEI number?

PT Kelola Biru H's FDA Establishment Identifier (FEI) is 3007840747.

Can shipments from PT Kelola Biru H still enter the U.S.?

Shipments of king fish from PT Kelola Biru H can be detained without physical examination under Import Alert 99-22; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).

PT Kelola Biru H

FDA import alert and refusal historyJakarta, IndonesiaFEI 3007840747

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As of October 26, 2026, PT Kelola Biru H (Jakarta, Indonesia) is on the red list of FDA Import Alert 99-22 (Undeclared or mislabeled major food allergens) for king fish, published by FDA on May 3, 2023, is also listed on Import Alert 16-04 (red list) and Import Alert 16-81 (red list) and Import Alert 16-105 (red list), and has 35 FDA import refusals recorded since October 2016.

Data from FDA public records, last checked October 26, 2026. Request a correction

Current status

Import alerts: IA 99-22 · red list IA 16-04 · red list IA 16-81 · red list IA 16-105 · red list
Last import refusal: Apr 28, 2023Kingfish (only menticirrhus spp) · LIST INGRE
Last warning letter: None found
Last inspection: May 15, 2018Classified NAI (No Action Indicated)

Every FDA record for PT Kelola Biru H

40 records, newest first. Each line links to the FDA page it came from.

2023

May 3, 2023Import alert listing
Listed on Import Alert 99-22red listKing Fish
Source
Apr 28, 2023Import refusal
Refused, Kingfish (only menticirrhus spp)LIST INGRE FALSE WRONG IDEN USUAL NAME ALLERGENEntry CDX-0083762-7
Source
Apr 26, 2023Import alert listing
Listed on Import Alert 16-04red listKing Fish
Source
Apr 5, 2023Import refusal
Refused, 6 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AMG-0150968-0Show 6 linesHide lines
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AMG-0150968-0Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AMG-0150968-0Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AMG-0150968-0Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AMG-0150968-0Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AMG-0150968-0Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AMG-0150968-0Source
Source
Mar 9, 2023Import refusal
Refused, 11 lines in one entry: Snapper (red, gray, malabar, etc.)SALMONELLAEntry CDX-0083762-7Show 11 linesHide lines
- Refused, Snapper (red, gray, malabar, etc.)SALMONELLAEntry CDX-0083762-7Source
- Refused, Snapper (red, gray, malabar, etc.)SALMONELLAEntry CDX-0083762-7Source
- Refused, Snapper (red, gray, malabar, etc.)SALMONELLAEntry CDX-0083762-7Source
- Refused, Snapper (red, gray, malabar, etc.)SALMONELLAEntry CDX-0083762-7Source
- Refused, Snapper (red, gray, malabar, etc.)SALMONELLAEntry CDX-0083762-7Source
- Refused, Snapper (red, gray, malabar, etc.)SALMONELLAEntry CDX-0083762-7Source
- Refused, Snapper (red, gray, malabar, etc.)SALMONELLAEntry CDX-0083762-7Source
- Refused, Snapper (red, gray, malabar, etc.)SALMONELLAEntry CDX-0083762-7Source
- Refused, Snapper (red, gray, malabar, etc.)SALMONELLAEntry CDX-0083762-7Source
- Refused, Snapper (red, gray, malabar, etc.)SALMONELLAEntry CDX-0083762-7Source
- Refused, Snapper (red, gray, malabar, etc.)SALMONELLAEntry CDX-0083762-7Source
Source
Feb 16, 2023Import alert listing
Listed on Import Alert 16-81red listScarlet Snapper Lutjanus sanguineus
Source

2022

Mar 28, 2022Import refusal
Refused, WahooFILTHYEntry AQZ-0527454-6
Source

2021

Nov 26, 2021Import refusal
Refused, 3 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry 991-0259830-9Show 3 linesHide lines
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry 991-0259830-9Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry 991-0259830-9Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry 991-0259830-9Source
Source

2019

Oct 3, 2019Import refusal
Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry 8P5-1002773-0
Source
Jul 16, 2019Import refusal
Refused, 3 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry 8P5-1002641-9Show 3 linesHide lines
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry 8P5-1002641-9Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry 8P5-1002641-9Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry 8P5-1002641-9Source
Source
Jul 15, 2019Import alert listing
Listed on Import Alert 16-105red listFrozen Tuna Steak
Source
May 7, 2019Import refusal
Refused, 4 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry 8P5-1002176-6Show 4 linesHide lines
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry 8P5-1002176-6Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry 8P5-1002176-6Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry 8P5-1002176-6Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry 8P5-1002176-6Source
Source
Mar 26, 2019Import refusal
Refused, 4 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.); Mahi mahiFILTHYEntry 8P5-1001662-6Show 4 linesHide lines
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry 8P5-1001662-6Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry 8P5-1001662-6Source
- Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry 8P5-1001662-6Source
- Refused, Mahi mahiFILTHYEntry 8P5-1001662-6Source
Source

2018

Nov 30, 2018Import refusal
Refused, Snapper (red, gray, malabar, etc.)FILTHYEntry 8P5-1000929-0
Source
May 15, 2018Inspection
Inspection classified NAI (No Action Indicated)Foodborne Biological Hazards
Source

Refusal charges, in plain English

FILTHY19 refused lines
Filthy, putrid or decomposed substance
The product appeared to consist in whole or in part of a filthy, putrid, or decomposed substance, or to be otherwise unfit for food.
SALMONELLA11 refused lines
Salmonella
The product appeared to contain Salmonella, which the law treats as a poisonous and deleterious substance that may make food injurious to health.
HISTAMINE4 refused lines
Histamine
The product appeared to contain histamine in a quantity that ordinarily makes it injurious to health.
ALLERGEN1 refused line
Major food allergen not declared
The label appeared not to declare all major food allergens present in the product, as section 403(w) of the FD&C Act requires.
FALSE1 refused line
False or misleading labeling
The labeling appeared to be false or misleading in some particular.
LIST INGRE1 refused line
Ingredients not listed
The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).
USUAL NAME1 refused line
Common or usual name missing
The label appeared not to show the common or usual name of the food.
WRONG IDEN1 refused line
WRONG IDEN

Questions about PT Kelola Biru H

Is PT Kelola Biru H on an FDA import alert?: Yes. As of October 26, 2026, PT Kelola Biru H is on the red list of FDA Import Alert 99-22, “Undeclared or mislabeled major food allergens”, for king fish; FDA published the listing on May 3, 2023.
Has FDA refused shipments from PT Kelola Biru H?: Yes. FDA refused 35 shipment lines from PT Kelola Biru H between November 30, 2018 and April 28, 2023. The most recent, on April 28, 2023, was kingfish (only menticirrhus spp), charged as LIST INGRE (ingredients not listed).
Why did FDA refuse PT Kelola Biru H's shipments?: The most frequent charges are FILTHY (filthy, putrid or decomposed substance, 19 lines) and SALMONELLA (salmonella, 11 lines).
When was PT Kelola Biru H last inspected by FDA?: FDA's most recent inspection of PT Kelola Biru H with a final classification is dated May 15, 2018 and was classified NAI (No Action Indicated).
What is PT Kelola Biru H's FEI number?: PT Kelola Biru H's FDA Establishment Identifier (FEI) is 3007840747.
Can shipments from PT Kelola Biru H still enter the U.S.?: Shipments of king fish from PT Kelola Biru H can be detained without physical examination under Import Alert 99-22; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.