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Hangzhou Jade Harmony Clothing Co.,

⚠️ High Risk

FEI: 3006776471 • Hangzhouhangzhou • CHINA

FEI

FEI Number

3006776471

📍

Location

Hangzhouhangzhou

🇨🇳

Country

CHINA
🏢

Address

Floor 1, No. 21 Of Yudao East Diru; Dist, Hangzhouhangzhou, , China

High Risk

FDA Import Risk Assessment

60.1
LowModerateHighCritical

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

Statistics

21
Total Refusals
2
Unique Violations
2/11/2009
Latest Refusal
2/11/2009
Earliest Refusal

Score Breakdown

Violation Severity
88.1×40%
Refusal Volume
49.7×30%
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

7520×

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).

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).

Refusal History

DateProductViolationsDivision
2/11/2009
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
2/11/2009
61JCS14SIMVASTATIN (ANTI-CHOLESTEREMIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
61NCS78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
62CAS41MINOXIDIL (ANTI-HYPERTENSIVE)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
62JCS99ANTI-PARKINSONIAN N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
62VDS12RIBAVIRIN (ANTI-VIRAL)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
56ICS76AZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
56ICS76AZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
56OCS01LEVAQUIN (FLUOROQUINOLONE)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
56ECS67OXYTETRACYCLINE HYDROCHLORIDE (TETRACYCLINES)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
56YJS99ANTIBIOTIC N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
56YCS99ANTIBIOTIC N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/11/2009
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Hangzhou Jade Harmony Clothing Co.,'s FDA import refusal history?

Hangzhou Jade Harmony Clothing Co., (FEI: 3006776471) has 21 FDA import refusal record(s) in our database, spanning from 2/11/2009 to 2/11/2009.

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. Hangzhou Jade Harmony Clothing Co.,'s FEI number is 3006776471.

What types of violations has Hangzhou Jade Harmony Clothing Co., received?

Hangzhou Jade Harmony Clothing Co., 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 Hangzhou Jade Harmony Clothing Co., come from?

All FDA import refusal data for Hangzhou Jade Harmony Clothing Co., 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.