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Tongliao Kailu Xingli Pharmaceutical Co., Ltd.

⚠️ Moderate Risk

FEI: 3004347962 • Tongliao, Neimengguzizhiqu • CHINA

FEI

FEI Number

3004347962

📍

Location

Tongliao, Neimengguzizhiqu

🇨🇳

Country

CHINA
🏢

Address

Kailu County 1, Gongnonglu; Keerqin, Tongliao, Neimengguzizhiqu, China

Moderate Risk

FDA Import Risk Assessment

38.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/22/2004
Latest Refusal
12/22/2004
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

24601×

UNSFDIETLB

The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.

Refusal History

DateProductViolationsDivision
12/22/2004
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
238UNSAFE ADD
2460UNSFDIETLB
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Tongliao Kailu Xingli Pharmaceutical Co., Ltd.'s FDA import refusal history?

Tongliao Kailu Xingli Pharmaceutical Co., Ltd. (FEI: 3004347962) has 1 FDA import refusal record(s) in our database, spanning from 12/22/2004 to 12/22/2004.

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. Tongliao Kailu Xingli Pharmaceutical Co., Ltd.'s FEI number is 3004347962.

What types of violations has Tongliao Kailu Xingli Pharmaceutical Co., Ltd. received?

Tongliao Kailu Xingli Pharmaceutical 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 Tongliao Kailu Xingli Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Tongliao Kailu Xingli 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.