Has FDA refused shipments from Okazaki bussan?

Yes. FDA refused 16 shipment lines from Okazaki bussan between August 29, 2017 and November 28, 2018. The most recent, on November 28, 2018, was imitation fruit, jam, jelly, preserves, marmalade, butter or candied, n.e.c., charged as UNSAFE COL (color additive unsafe under section 721).

Why did FDA refuse Okazaki bussan's shipments?

The most frequent charge is UNSAFE COL (color additive unsafe under section 721, 16 lines).

What is Okazaki bussan's FEI number?

Okazaki bussan's FDA Establishment Identifier (FEI) is 3013188190.

Can shipments from Okazaki bussan still enter the U.S.?

Shipments of jelly mix from Okazaki bussan can be detained without physical examination under Import Alert 45-02; 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).

Okazaki bussan

FDA import alert and refusal historyKoshigaya, JapanFEI 3013188190

Watch this supplier

As of October 26, 2026, Okazaki bussan (Koshigaya, Japan) is on the red list of FDA Import Alert 45-02 (Foods with illegal or undeclared colors) for jelly mix, published by FDA on June 18, 2013, and has 16 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 45-02 · red list
Last import refusal: Nov 28, 2018Imitation fruit, jam, jelly, preserves, marmalade, butter or candied, n.e.c. · UNSAFE COL
Last warning letter: None found
Last inspection: None on record

Every FDA record for Okazaki bussan

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

2018

Nov 28, 2018Import refusal
Refused, Imitation fruit, jam, jelly, preserves, marmalade, butter or candied, n.e.c.UNSAFE COLEntry 9ES-0043160-9
Source

2017

Dec 21, 2017Import refusal
Refused, 3 lines in one entry: Gel cups candyUNSAFE COLEntry 235-1595468-5Show 3 linesHide lines
- Refused, Gel cups candyUNSAFE COLEntry 235-1595468-5Source
- Refused, Gel cups candyUNSAFE COLEntry 235-1595468-5Source
- Refused, Gel cups candyUNSAFE COLEntry 235-1595468-5Source
Source
Nov 29, 2017Import refusal
Refused, 3 lines in one entry: Gel cups candyUNSAFE COLEntry 235-1595554-2Show 3 linesHide lines
- Refused, Gel cups candyUNSAFE COLEntry 235-1595554-2Source
- Refused, Gel cups candyUNSAFE COLEntry 235-1595554-2Source
- Refused, Gel cups candyUNSAFE COLEntry 235-1595554-2Source
Source
Nov 21, 2017Import refusal
Refused, 2 lines in one entry: Gel cups candyUNSAFE COLEntry 235-1594805-9Show 2 linesHide lines
- Refused, Gel cups candyUNSAFE COLEntry 235-1594805-9Source
- Refused, Gel cups candyUNSAFE COLEntry 235-1594805-9Source
Source
Nov 2, 2017Import refusal
Refused, Gel cups candyUNSAFE COLEntry 235-1591915-9
Source
Nov 2, 2017Import refusal
Refused, 2 lines in one entry: Gel cups candyUNSAFE COLEntry 235-1593625-2Show 2 linesHide lines
- Refused, Gel cups candyUNSAFE COLEntry 235-1593625-2Source
- Refused, Gel cups candyUNSAFE COLEntry 235-1593625-2Source
Source
Nov 2, 2017Import refusal
Refused, Gel cups candyUNSAFE COLEntry 235-1591479-6
Source
Oct 26, 2017Import refusal
Refused, 2 lines in one entry: Gel cups candyUNSAFE COLEntry 235-1593102-2Show 2 linesHide lines
- Refused, Gel cups candyUNSAFE COLEntry 235-1593102-2Source
- Refused, Gel cups candyUNSAFE COLEntry 235-1593102-2Source
Source
Aug 29, 2017Import refusal
Refused, Gel cups candyUNSAFE COLEntry 235-1591633-8
Source

2013

Jun 18, 2013Import alert listing
Listed on Import Alert 45-02red listJelly Mix
Source

Refusal charges, in plain English

UNSAFE COL16 refused lines
Color additive unsafe under section 721
The product appeared to be, or to contain, a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act, the section that governs which color additives may be used and how.

Questions about Okazaki bussan

Is Okazaki bussan on an FDA import alert?: Yes. As of October 26, 2026, Okazaki bussan is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for jelly mix; FDA published the listing on June 18, 2013.
Has FDA refused shipments from Okazaki bussan?: Yes. FDA refused 16 shipment lines from Okazaki bussan between August 29, 2017 and November 28, 2018. The most recent, on November 28, 2018, was imitation fruit, jam, jelly, preserves, marmalade, butter or candied, n.e.c., charged as UNSAFE COL (color additive unsafe under section 721).
Why did FDA refuse Okazaki bussan's shipments?: The most frequent charge is UNSAFE COL (color additive unsafe under section 721, 16 lines).
What is Okazaki bussan's FEI number?: Okazaki bussan's FDA Establishment Identifier (FEI) is 3013188190.
Can shipments from Okazaki bussan still enter the U.S.?: Shipments of jelly mix from Okazaki bussan can be detained without physical examination under Import Alert 45-02; 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).

Watch this supplier

Get an email when FDA publishes anything new on Okazaki bussan.

An email with the FDA source, and a dated PDF for your FSVP file. First supplier free.

Watch this supplier

Related records

Similar suppliers in Japan

Guides

Get this record's changes by email

Watch this supplier

Buying from Okazaki bussan?

Watch it and get the FDA record the day it changes. Free for one supplier.

Watch this supplier

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.