NingBo Huiyoo Baby Products Co., Ltd.
⚠️ Moderate Risk
FEI: 3014759586 • Cixi Ningbo, Zhejiang • CHINA
FEI Number
3014759586
Location
Cixi Ningbo, Zhejiang
Country
CHINAAddress
# 523, Cizhang Road; Zhangqi Industrial Area Cixi City, Cixi Ningbo, Zhejiang, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/20/2025 | 85HGXPUMP, BREAST, POWERED | 237NO PMA | Division of Northeast Imports (DNEI) |
| 1/17/2024 | 85HGXPUMP, BREAST, POWERED | Division of West Coast Imports (DWCI) | |
| 3/23/2023 | 85HGXPUMP, BREAST, POWERED | Division of West Coast Imports (DWCI) | |
| 3/22/2023 | 85HGXPUMP, BREAST, POWERED | Division of West Coast Imports (DWCI) | |
| 3/14/2023 | 85HGXPUMP, BREAST, POWERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is NingBo Huiyoo Baby Products Co., Ltd.'s FDA import refusal history?
NingBo Huiyoo Baby Products Co., Ltd. (FEI: 3014759586) has 5 FDA import refusal record(s) in our database, spanning from 3/14/2023 to 5/20/2025.
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. NingBo Huiyoo Baby Products Co., Ltd.'s FEI number is 3014759586.
What types of violations has NingBo Huiyoo Baby Products Co., Ltd. received?
NingBo Huiyoo Baby Products Co., Ltd. has been cited for 6 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 NingBo Huiyoo Baby Products Co., Ltd. come from?
All FDA import refusal data for NingBo Huiyoo Baby Products 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.