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WICHITHRA Vacuum Dehydrated Natural Foods

⚠️ Moderate Risk

FEI: 3010957566 • Bemmulla, Gampaha • SRI LANKA

FEI

FEI Number

3010957566

📍

Location

Bemmulla, Gampaha

🇱🇰

Country

SRI LANKA
🏢

Address

382, Vigoda Road, Doranagoda, , Bemmulla, Gampaha, Sri Lanka

Moderate Risk

FDA Import Risk Assessment

44.1
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
8/7/2008
Latest Refusal
8/7/2008
Earliest Refusal

Score Breakdown

Violation Severity
71.8×40%
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

756×

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).

1185×

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).

Refusal History

DateProductViolationsDivision
8/7/2008
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Baltimore District Office (BLT-DO)
8/7/2008
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Baltimore District Office (BLT-DO)
8/7/2008
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Baltimore District Office (BLT-DO)
8/7/2008
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Baltimore District Office (BLT-DO)
8/7/2008
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Baltimore District Office (BLT-DO)
8/7/2008
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is WICHITHRA Vacuum Dehydrated Natural Foods's FDA import refusal history?

WICHITHRA Vacuum Dehydrated Natural Foods (FEI: 3010957566) has 6 FDA import refusal record(s) in our database, spanning from 8/7/2008 to 8/7/2008.

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. WICHITHRA Vacuum Dehydrated Natural Foods's FEI number is 3010957566.

What types of violations has WICHITHRA Vacuum Dehydrated Natural Foods received?

WICHITHRA Vacuum Dehydrated Natural Foods has been cited for 2 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 WICHITHRA Vacuum Dehydrated Natural Foods come from?

All FDA import refusal data for WICHITHRA Vacuum Dehydrated Natural Foods 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.