NINGBO LONGWELL BABY PRODUCTS CO., LTD
⚠️ Moderate Risk
FEI: 3009109684 • Ningbo, Zhejiang • CHINA
FEI Number
3009109684
Location
Ningbo, Zhejiang
Country
CHINAAddress
No.77, Lane 520 Tongning Road, , 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/26/2024 | 76MEFRING, TEETHING, NON-FLUID FILLED | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/26/2024 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/6/2018 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is NINGBO LONGWELL BABY PRODUCTS CO., LTD's FDA import refusal history?
NINGBO LONGWELL BABY PRODUCTS CO., LTD (FEI: 3009109684) has 3 FDA import refusal record(s) in our database, spanning from 6/6/2018 to 4/26/2024.
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 LONGWELL BABY PRODUCTS CO., LTD's FEI number is 3009109684.
What types of violations has NINGBO LONGWELL BABY PRODUCTS CO., LTD received?
NINGBO LONGWELL BABY PRODUCTS 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 NINGBO LONGWELL BABY PRODUCTS CO., LTD come from?
All FDA import refusal data for NINGBO LONGWELL 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.