Shanghai D-K International Trade Corp.
⚠️ Moderate Risk
FEI: 1000460367 • Shanghai • CHINA
FEI Number
1000460367
Location
Shanghai
Country
CHINAAddress
No. 9 Ren Min Da Dao, , 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
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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).
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).
DIET INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/15/2014 | 61HAS03TRIMETHOPRIM (ANTI-BACTERIAL) | Los Angeles District Office (LOS-DO) | |
| 9/29/2007 | 60TAS05CIMETIDINE (ANTAGONIST) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/24/2007 | 54ABY99VITAMIN, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 7/12/2007 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 1/9/2007 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 9/5/2006 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 8/18/2006 | 55PP97METHYL SALICYLATE (PHARMACEUTIC NECESSITY - FLAVOR) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/12/2006 | 60LAR05ASPIRIN (ANALGESIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/23/2006 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2200DIET INGRE | Los Angeles District Office (LOS-DO) |
| 1/23/2006 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 1/23/2006 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 12/13/2005 | 60QCR46PROCAINE HCL (ANESTHETIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shanghai D-K International Trade Corp.'s FDA import refusal history?
Shanghai D-K International Trade Corp. (FEI: 1000460367) has 12 FDA import refusal record(s) in our database, spanning from 12/13/2005 to 9/15/2014.
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 D-K International Trade Corp.'s FEI number is 1000460367.
What types of violations has Shanghai D-K International Trade Corp. received?
Shanghai D-K International Trade Corp. has been cited for 4 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 D-K International Trade Corp. come from?
All FDA import refusal data for Shanghai D-K International Trade Corp. 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.