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Jilin Longyuan Health Food Co. Ltd.

⚠️ Moderate Risk

FEI: 3004333114 • Jilin, Jilin • CHINA

FEI

FEI Number

3004333114

📍

Location

Jilin, Jilin

🇨🇳

Country

CHINA
🏢

Address

No 13 Heping Main Street Tiehe West Rd, Changyihadawan St., Jilin, Jilin, China

Moderate Risk

FDA Import Risk Assessment

38.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
12/12/2005
Latest Refusal
12/12/2005
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

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).

Refusal History

DateProductViolationsDivision
12/12/2005
60LBL99ANALGESIC, N.E.C.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
12/12/2005
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Jilin Longyuan Health Food Co. Ltd.'s FDA import refusal history?

Jilin Longyuan Health Food Co. Ltd. (FEI: 3004333114) has 2 FDA import refusal record(s) in our database, spanning from 12/12/2005 to 12/12/2005.

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. Jilin Longyuan Health Food Co. Ltd.'s FEI number is 3004333114.

What types of violations has Jilin Longyuan Health Food Co. Ltd. received?

Jilin Longyuan Health Food Co. Ltd. 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 Jilin Longyuan Health Food Co. Ltd. come from?

All FDA import refusal data for Jilin Longyuan Health Food 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.