Gansu Provincial Import & Export
⚠️ High Risk
FEI: 3003162392 • Lanzhou • CHINA
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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).
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
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.
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.
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
DISEASED
The food appears to be, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/18/2006 | 54FCA19MAGNOLIA (HERBAL & BOTANICALS, NOT TEAS) | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 1/18/2006 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 1/18/2006 | 54FCA19MAGNOLIA (HERBAL & BOTANICALS, NOT TEAS) | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 1/18/2006 | 54FCA19MAGNOLIA (HERBAL & BOTANICALS, NOT TEAS) | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 1/18/2006 | 54FCA33ASTRAGALUS (MILK VETCH ROOT), (HERBAL & BOTANICALS, NOT TEAS) | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 1/18/2006 | 54FCA01ACONITE (HERBAL & BOTANICALS, NOT TEAS) | Los Angeles District Office (LOS-DO) | |
| 1/18/2006 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/18/2006 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 4/20/2005 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | 488HEALTH C | Los Angeles District Office (LOS-DO) |
| 4/20/2005 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | 488HEALTH C | Los Angeles District Office (LOS-DO) |
| 4/20/2005 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | 488HEALTH C | Los Angeles District Office (LOS-DO) |
| 4/20/2005 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 4/20/2005 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 4/20/2005 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 4/20/2005 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 4/20/2005 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 4/20/2005 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 4/20/2005 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 4/20/2005 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 3/15/2002 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 251POISONOUS | Los Angeles District Office (LOS-DO) |
| 3/15/2002 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 251POISONOUS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Gansu Provincial Import & Export's FDA import refusal history?
Gansu Provincial Import & Export (FEI: 3003162392) has 21 FDA import refusal record(s) in our database, spanning from 3/15/2002 to 1/18/2006.
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. Gansu Provincial Import & Export's FEI number is 3003162392.
What types of violations has Gansu Provincial Import & Export received?
Gansu Provincial Import & Export has been cited for 9 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 Gansu Provincial Import & Export come from?
All FDA import refusal data for Gansu Provincial Import & Export 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.