SHANGHAI LIGHT INDUSTRIAL PRODUCTS IMP.&EXP.CORP.LTD.
⚠️ Moderate Risk
FEI: 3007038973 • Shanghai, Shanghai • CHINA
FEI Number
3007038973
Location
Shanghai, Shanghai
Country
CHINAAddress
Room 1605-1607, No. 501 Wuning Road, 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
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).
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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).
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).
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 |
|---|---|---|---|
| 8/24/2011 | 66SCS44XANTHINOL NIACINATE (VASODILATOR) | New Orleans District Office (NOL-DO) | |
| 8/20/2009 | 53IC01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 310POISONOUS | New Orleans District Office (NOL-DO) |
| 8/20/2009 | 53IC01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 310POISONOUS | New Orleans District Office (NOL-DO) |
| 8/20/2009 | 76JESFLOSS, DENTAL | New Orleans District Office (NOL-DO) | |
| 8/20/2009 | 76EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY | New Orleans District Office (NOL-DO) | |
| 8/21/2007 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is SHANGHAI LIGHT INDUSTRIAL PRODUCTS IMP.&EXP.CORP.LTD.'s FDA import refusal history?
SHANGHAI LIGHT INDUSTRIAL PRODUCTS IMP.&EXP.CORP.LTD. (FEI: 3007038973) has 6 FDA import refusal record(s) in our database, spanning from 8/21/2007 to 8/24/2011.
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 LIGHT INDUSTRIAL PRODUCTS IMP.&EXP.CORP.LTD.'s FEI number is 3007038973.
What types of violations has SHANGHAI LIGHT INDUSTRIAL PRODUCTS IMP.&EXP.CORP.LTD. received?
SHANGHAI LIGHT INDUSTRIAL PRODUCTS IMP.&EXP.CORP.LTD. has been cited for 5 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 LIGHT INDUSTRIAL PRODUCTS IMP.&EXP.CORP.LTD. come from?
All FDA import refusal data for SHANGHAI LIGHT INDUSTRIAL PRODUCTS IMP.&EXP.CORP.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.