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CV MELDA FAMILY

⚠️ High Risk

FEI: 3018549424 • Pontianak, Kalimantan Barat • INDONESIA

FEI

FEI Number

3018549424

📍

Location

Pontianak, Kalimantan Barat

🇮🇩

Country

INDONESIA
🏢

Address

Rt 001 Rw 022, Jln. Husein Mamzah No 35; Gangmelda, Pontianak, Kalimantan Barat, Indonesia

High Risk

FDA Import Risk Assessment

59.8
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

11
Total Refusals
5
Unique Violations
3/31/2022
Latest Refusal
2/16/2021
Earliest Refusal

Score Breakdown

Violation Severity
82.7×40%
Refusal Volume
40.0×30%
Recency
24.3×20%
Frequency
98.4×10%
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

21207×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

2383×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

753×

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).

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

39001×

NDIDIETSP

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a food that is a dietary supplement or that contains a dietary ingredient that is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

Refusal History

DateProductViolationsDivision
3/31/2022
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
Division of Southwest Imports (DSWI)
3/22/2022
54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
238UNSAFE ADD
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/17/2022
54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
3900NDIDIETSP
Division of Southeast Imports (DSEI)
2/15/2022
54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
238UNSAFE ADD
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/11/2022
54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2280DIRSEXMPT
238UNSAFE ADD
75UNAPPROVED
Division of Southeast Imports (DSEI)
12/3/2021
54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
Division of Southeast Imports (DSEI)
8/27/2021
54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
Division of Southeast Imports (DSEI)
8/13/2021
54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
Division of Southeast Imports (DSEI)
4/13/2021
54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
Division of Southeast Imports (DSEI)
4/13/2021
54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
Division of Southeast Imports (DSEI)
2/16/2021
54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CV MELDA FAMILY's FDA import refusal history?

CV MELDA FAMILY (FEI: 3018549424) has 11 FDA import refusal record(s) in our database, spanning from 2/16/2021 to 3/31/2022.

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. CV MELDA FAMILY's FEI number is 3018549424.

What types of violations has CV MELDA FAMILY received?

CV MELDA FAMILY has been cited for 5 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 CV MELDA FAMILY come from?

All FDA import refusal data for CV MELDA FAMILY 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.