Nanjing Chrise Medical Material Co Ltd
⚠️ Moderate Risk
FEI: 3003955861 • Nanjing • 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).
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.
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:
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
SBGINSENG
The article is subject to refusal of admission in that it appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are not an herb or herbal ingredient derived from a plant classified within the genus Panax.
MELAMINE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.
UNFIT4FOOD
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food.
PESTICIDE2
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/10/2013 | 25JGT31GINSENG (ROOT & TUBER VEGETABLE) | Los Angeles District Office (LOS-DO) | |
| 10/10/2013 | 02GGT08SOYBEAN FLOUR, MEAL, OR POWDER | Los Angeles District Office (LOS-DO) | |
| 1/30/2008 | 54YBT04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | 2920PESTICIDES | Los Angeles District Office (LOS-DO) |
| 5/23/2006 | 66YOR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/13/2006 | 24TGH99LEAF & STEM VEGETABLES, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Nanjing Chrise Medical Material Co Ltd's FDA import refusal history?
Nanjing Chrise Medical Material Co Ltd (FEI: 3003955861) has 5 FDA import refusal record(s) in our database, spanning from 4/13/2006 to 10/10/2013.
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. Nanjing Chrise Medical Material Co Ltd's FEI number is 3003955861.
What types of violations has Nanjing Chrise Medical Material Co Ltd received?
Nanjing Chrise Medical Material Co Ltd 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 Nanjing Chrise Medical Material Co Ltd come from?
All FDA import refusal data for Nanjing Chrise Medical Material Co 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.