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Wecare Probiotics Co., Ltd.

⚠️ Moderate Risk

FEI: 3017833829 • Suzhou, Jiangsu • CHINA

FEI

FEI Number

3017833829

📍

Location

Suzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

No. 1033 Long Qiao Road,Wujiang, , Suzhou, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

45.4
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
3/26/2025
Latest Refusal
6/11/2018
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
68.8×20%
Frequency
2.9×10%
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

2561×

INCONSPICU

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

34211×

MELAMINE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.

Refusal History

DateProductViolationsDivision
3/26/2025
09EFT29MILK AND MILK PRODUCTS, ADDED SAFE AND SUITABLE MICROBIAL ORGANISMS (E.G. LACTOBACILLUS ACIDOPHILUS)
3421MELAMINE
Division of Southeast Imports (DSEI)
6/11/2018
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
256INCONSPICU
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Wecare Probiotics Co., Ltd.'s FDA import refusal history?

Wecare Probiotics Co., Ltd. (FEI: 3017833829) has 2 FDA import refusal record(s) in our database, spanning from 6/11/2018 to 3/26/2025.

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. Wecare Probiotics Co., Ltd.'s FEI number is 3017833829.

What types of violations has Wecare Probiotics Co., Ltd. received?

Wecare Probiotics 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 Wecare Probiotics Co., Ltd. come from?

All FDA import refusal data for Wecare Probiotics 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.