Shanghai Youlong Rubber Products Company
⚠️ Moderate Risk
FEI: 3007664035 • Shanghai, Shanghai • CHINA
FEI Number
3007664035
Location
Shanghai, Shanghai
Country
CHINAAddress
1 Xing Chun Cun Huang Lou Pudong, , Shanghai, Shanghai, 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/10/2016 | 80FRLFIBER, MEDICAL, ABSORBENT | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 1/8/2016 | 80FRLFIBER, MEDICAL, ABSORBENT | Southwest Import District Office (SWI-DO) | |
| 1/8/2016 | 80FRLFIBER, MEDICAL, ABSORBENT | Southwest Import District Office (SWI-DO) | |
| 1/8/2016 | 80FRLFIBER, MEDICAL, ABSORBENT | Southwest Import District Office (SWI-DO) | |
| 1/4/2016 | 79HMPPAD, EYE | Southwest Import District Office (SWI-DO) | |
| 1/4/2016 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | Southwest Import District Office (SWI-DO) | |
| 1/4/2016 | 80FRLFIBER, MEDICAL, ABSORBENT | Southwest Import District Office (SWI-DO) | |
| 1/4/2016 | 79HMPPAD, EYE | Southwest Import District Office (SWI-DO) | |
| 1/4/2016 | 80FRLFIBER, MEDICAL, ABSORBENT | Southwest Import District Office (SWI-DO) | |
| 1/4/2016 | 79HMPPAD, EYE | Southwest Import District Office (SWI-DO) | |
| 1/4/2016 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | Southwest Import District Office (SWI-DO) | |
| 1/4/2016 | 80FRLFIBER, MEDICAL, ABSORBENT | Southwest Import District Office (SWI-DO) | |
| 12/11/2015 | 79HMPPAD, EYE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/11/2015 | 79HMPPAD, EYE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/11/2015 | 79HMPPAD, EYE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/9/2015 | 80FRLFIBER, MEDICAL, ABSORBENT | Southwest Import District Office (SWI-DO) | |
| 12/9/2015 | 80FRLFIBER, MEDICAL, ABSORBENT | Southwest Import District Office (SWI-DO) | |
| 12/9/2015 | 79KCXEPILATOR, HIGH FREQUENCY, TWEEZER-TYPE | Southwest Import District Office (SWI-DO) | |
| 12/8/2015 | 79HMPPAD, EYE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 80FRLFIBER, MEDICAL, ABSORBENT | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 80FRLFIBER, MEDICAL, ABSORBENT | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 79HMPPAD, EYE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 80FRLFIBER, MEDICAL, ABSORBENT | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 80FRLFIBER, MEDICAL, ABSORBENT | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 79HMPPAD, EYE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 80FRLFIBER, MEDICAL, ABSORBENT | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 80FRLFIBER, MEDICAL, ABSORBENT | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 12/8/2015 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Shanghai Youlong Rubber Products Company's FDA import refusal history?
Shanghai Youlong Rubber Products Company (FEI: 3007664035) has 36 FDA import refusal record(s) in our database, spanning from 12/8/2015 to 2/10/2016.
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. Shanghai Youlong Rubber Products Company's FEI number is 3007664035.
What types of violations has Shanghai Youlong Rubber Products Company received?
Shanghai Youlong Rubber Products Company 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 Shanghai Youlong Rubber Products Company come from?
All FDA import refusal data for Shanghai Youlong Rubber Products Company 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.