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Zara Natural Dead Sea Products

⚠️ Moderate Risk

FEI: 1000333840 • Amman, The Capital • JORDAN

FEI

FEI Number

1000333840

📍

Location

Amman, The Capital

🇯🇴

Country

JORDAN
🏢

Address

P.O. Box 2585, , Amman, The Capital, Jordan

Moderate Risk

FDA Import Risk Assessment

32.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
4
Unique Violations
11/13/2003
Latest Refusal
5/12/2003
Earliest Refusal

Score Breakdown

Violation Severity
58.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
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

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

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).

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

3101×

POISONOUS

The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.

Refusal History

DateProductViolationsDivision
11/13/2003
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
473LABELING
Los Angeles District Office (LOS-DO)
11/13/2003
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
223FALSE
Los Angeles District Office (LOS-DO)
5/12/2003
53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
310POISONOUS
473LABELING
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Zara Natural Dead Sea Products's FDA import refusal history?

Zara Natural Dead Sea Products (FEI: 1000333840) has 3 FDA import refusal record(s) in our database, spanning from 5/12/2003 to 11/13/2003.

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. Zara Natural Dead Sea Products's FEI number is 1000333840.

What types of violations has Zara Natural Dead Sea Products received?

Zara Natural Dead Sea Products has been cited for 4 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 Zara Natural Dead Sea Products come from?

All FDA import refusal data for Zara Natural Dead Sea Products 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.