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Beijing Mebo High Technology Co Ltd

⚠️ Moderate Risk

FEI: 3009916781 • Changpng, Beijingsh • CHINA

FEI

FEI Number

3009916781

📍

Location

Changpng, Beijingsh

🇨🇳

Country

CHINA
🏢

Address

Yard No 26 Nan Xin Lu, , Changpng, Beijingsh, China

Moderate Risk

FDA Import Risk Assessment

46.1
LowModerateHighCritical

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

Statistics

11
Total Refusals
5
Unique Violations
6/25/2014
Latest Refusal
5/9/2013
Earliest Refusal

Score Breakdown

Violation Severity
61.0×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
97.5×10%
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

7510×

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).

4727×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

4731×

LABELING

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

Refusal History

DateProductViolationsDivision
6/25/2014
66VBA99MISCELLANEOUS PATENT MEDICINES, ETC.
335LACKS N/C
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2014
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
3260NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2014
53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
473LABELING
Los Angeles District Office (LOS-DO)
6/15/2014
66VD99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2014
66VD99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2014
66VD99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2014
66VC99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2014
66VC99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2014
66VD99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2014
66YST99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
472NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)
5/9/2013
46YH99FOOD ADDITIVES FOR HUMAN USE, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Beijing Mebo High Technology Co Ltd's FDA import refusal history?

Beijing Mebo High Technology Co Ltd (FEI: 3009916781) has 11 FDA import refusal record(s) in our database, spanning from 5/9/2013 to 6/25/2014.

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. Beijing Mebo High Technology Co Ltd's FEI number is 3009916781.

What types of violations has Beijing Mebo High Technology Co Ltd received?

Beijing Mebo High Technology Co Ltd 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 Beijing Mebo High Technology Co Ltd come from?

All FDA import refusal data for Beijing Mebo High Technology Co Ltd 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.