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ETERNITY J&K CO.

⚠️ Moderate Risk

FEI: 3027688868 • Cavite, Calabarzon • PHILIPPINES

FEI

FEI Number

3027688868

📍

Location

Cavite, Calabarzon

🇵🇭
🏢

Address

71 Malagasang 1-E Imuscavite, Malagasang Road, Cavite, Calabarzon, Philippines

Moderate Risk

FDA Import Risk Assessment

42.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
9/7/2023
Latest Refusal
9/7/2023
Earliest Refusal

Score Breakdown

Violation Severity
64.0×40%
Refusal Volume
22.3×30%
Recency
38.0×20%
Frequency
30.0×10%
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

1182×

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).

752×

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).

4821×

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.

Refusal History

DateProductViolationsDivision
9/7/2023
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
482NUTRIT LBL
Division of Southeast Imports (DSEI)
9/7/2023
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/7/2023
66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ETERNITY J&K CO.'s FDA import refusal history?

ETERNITY J&K CO. (FEI: 3027688868) has 3 FDA import refusal record(s) in our database, spanning from 9/7/2023 to 9/7/2023.

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. ETERNITY J&K CO.'s FEI number is 3027688868.

What types of violations has ETERNITY J&K CO. received?

ETERNITY J&K CO. has been cited for 3 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 ETERNITY J&K CO. come from?

All FDA import refusal data for ETERNITY J&K CO. 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.