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Biokor Metics Ltd Cosmetic Products

⚠️ Moderate Risk

FEI: 3003171480 • Bnei Brak • ISRAEL

FEI

FEI Number

3003171480

📍

Location

Bnei Brak

🇮🇱

Country

ISRAEL
🏢

Address

7 Hahashmonaim Street, , Bnei Brak, , Israel

Moderate Risk

FDA Import Risk Assessment

43.4
LowModerateHighCritical

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

Statistics

12
Total Refusals
4
Unique Violations
4/24/2006
Latest Refusal
7/29/2005
Earliest Refusal

Score Breakdown

Violation Severity
52.6×40%
Refusal Volume
41.3×30%
Recency
0.0×20%
Frequency
100.0×10%
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

11812×

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).

3338×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

758×

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).

4833×

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.

Refusal History

DateProductViolationsDivision
4/24/2006
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
San Francisco District Office (SAN-DO)
4/24/2006
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
San Francisco District Office (SAN-DO)
4/6/2006
63VBJ99DEPIGMENTOR N.E.C.
118NOT LISTED
333LACKS FIRM
483DRUG NAME
75UNAPPROVED
San Francisco District Office (SAN-DO)
4/6/2006
63VCJ99DEPIGMENTOR N.E.C.
118NOT LISTED
333LACKS FIRM
483DRUG NAME
75UNAPPROVED
San Francisco District Office (SAN-DO)
4/6/2006
61SBJ99ANTI-ECZEMATIC N.E.C.
118NOT LISTED
333LACKS FIRM
483DRUG NAME
75UNAPPROVED
San Francisco District Office (SAN-DO)
7/29/2005
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
333LACKS FIRM
75UNAPPROVED
San Francisco District Office (SAN-DO)
7/29/2005
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
333LACKS FIRM
75UNAPPROVED
San Francisco District Office (SAN-DO)
7/29/2005
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
333LACKS FIRM
75UNAPPROVED
San Francisco District Office (SAN-DO)
7/29/2005
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
333LACKS FIRM
75UNAPPROVED
San Francisco District Office (SAN-DO)
7/29/2005
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
333LACKS FIRM
75UNAPPROVED
San Francisco District Office (SAN-DO)
7/29/2005
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
118NOT LISTED
San Francisco District Office (SAN-DO)
7/29/2005
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Biokor Metics Ltd Cosmetic Products's FDA import refusal history?

Biokor Metics Ltd Cosmetic Products (FEI: 3003171480) has 12 FDA import refusal record(s) in our database, spanning from 7/29/2005 to 4/24/2006.

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. Biokor Metics Ltd Cosmetic Products's FEI number is 3003171480.

What types of violations has Biokor Metics Ltd Cosmetic Products received?

Biokor Metics Ltd Cosmetic 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 Biokor Metics Ltd Cosmetic Products come from?

All FDA import refusal data for Biokor Metics Ltd Cosmetic 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.