Longbow First Aid Products Manufactory
⚠️ Moderate Risk
FEI: 3006102089 • Foshan, Guangdong • CHINA
FEI Number
3006102089
Location
Foshan, Guangdong
Country
CHINAAddress
Hantian Industrial Park, Building F/2, A3 Guiping Road, Foshan, Guangdong, 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/4/2024 | 65FAY06WATER, PURIFIED (EYEWASH) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/11/2020 | 65FBY06WATER, PURIFIED (EYEWASH) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/29/2014 | 79OHOFIRST AID KIT WITHOUT DRUG | Philadelphia District Office (PHI-DO) | |
| 7/29/2014 | 79OHOFIRST AID KIT WITHOUT DRUG | Philadelphia District Office (PHI-DO) | |
| 7/21/2014 | 79OHOFIRST AID KIT WITHOUT DRUG | Philadelphia District Office (PHI-DO) | |
| 7/21/2014 | 79OHOFIRST AID KIT WITHOUT DRUG | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Longbow First Aid Products Manufactory's FDA import refusal history?
Longbow First Aid Products Manufactory (FEI: 3006102089) has 6 FDA import refusal record(s) in our database, spanning from 7/21/2014 to 6/4/2024.
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. Longbow First Aid Products Manufactory's FEI number is 3006102089.
What types of violations has Longbow First Aid Products Manufactory received?
Longbow First Aid Products Manufactory 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 Longbow First Aid Products Manufactory come from?
All FDA import refusal data for Longbow First Aid Products Manufactory 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.