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Seajay Exports

⚠️ Moderate Risk

FEI: 3004580076 • Lami • FIJI

FEI

FEI Number

3004580076

📍

Location

Lami

🇫🇯

Country

FIJI
🏢

Address

Lot 1 Wailukutu Subdivision, , Lami, , Fiji

Moderate Risk

FDA Import Risk Assessment

38.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

6
Total Refusals
10
Unique Violations
5/9/2006
Latest Refusal
6/6/2005
Earliest Refusal

Score Breakdown

Violation Severity
57.2×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

2184×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

4823×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

113×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

642×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

3211×

LACKS N/C

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

Refusal History

DateProductViolationsDivision
5/9/2006
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
218LIST INGRE
San Francisco District Office (SAN-DO)
3/16/2006
34GFT01CHOCOLATE CANDY BAR, WITH NUTS AND FRUIT
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
San Francisco District Office (SAN-DO)
3/16/2006
07BGT99FRIED SNACK FOODS, N.E.C.
11UNSAFE COL
218LIST INGRE
482NUTRIT LBL
64YELLOW #5
San Francisco District Office (SAN-DO)
3/16/2006
07BGT99FRIED SNACK FOODS, N.E.C.
11UNSAFE COL
218LIST INGRE
482NUTRIT LBL
64YELLOW #5
San Francisco District Office (SAN-DO)
8/9/2005
33SFT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
San Francisco District Office (SAN-DO)
6/6/2005
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
16DIRECTIONS
178COL ADDED
483DRUG NAME
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Seajay Exports's FDA import refusal history?

Seajay Exports (FEI: 3004580076) has 6 FDA import refusal record(s) in our database, spanning from 6/6/2005 to 5/9/2006.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Seajay Exports's FEI number is 3004580076.

What types of violations has Seajay Exports received?

Seajay Exports has been cited for 10 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Seajay Exports come from?

All FDA import refusal data for Seajay Exports is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.