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Hunan KYF Pharmaceutical. Co., Ltd

⚠️ Moderate Risk

FEI: 3003657679 • Jin, Hunan • CHINA

FEI

FEI Number

3003657679

📍

Location

Jin, Hunan

🇨🇳

Country

CHINA
🏢

Address

Jinshi Avenue Industrial Park, No. 001; Area, Jin, Hunan, China

Moderate Risk

FDA Import Risk Assessment

38.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
10/26/2007
Latest Refusal
6/5/2006
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
21.6×10%
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

752×

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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
10/26/2007
64GCZ22NYLESTRIOL (ESTROGEN)
16DIRECTIONS
Minneapolis District Office (MIN-DO)
9/20/2006
60DNB99ADRENOCORTICAL STEROID N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
6/5/2006
64GCS99ESTROGEN N.E.C.
75UNAPPROVED
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Hunan KYF Pharmaceutical. Co., Ltd's FDA import refusal history?

Hunan KYF Pharmaceutical. Co., Ltd (FEI: 3003657679) has 3 FDA import refusal record(s) in our database, spanning from 6/5/2006 to 10/26/2007.

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. Hunan KYF Pharmaceutical. Co., Ltd's FEI number is 3003657679.

What types of violations has Hunan KYF Pharmaceutical. Co., Ltd received?

Hunan KYF Pharmaceutical. Co., Ltd has been cited for 3 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 Hunan KYF Pharmaceutical. Co., Ltd come from?

All FDA import refusal data for Hunan KYF Pharmaceutical. 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.