Fenchem Biotek Ltd.
⚠️ Moderate Risk
FEI: 3013257323 • Nanjing, Jiangsu • CHINA
FEI Number
3013257323
Location
Nanjing, Jiangsu
Country
CHINAAddress
Fortune Building No. 1911, No. 359 Hongwu Road, Nanjing, Jiangsu, 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
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).
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:
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.
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:
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/29/2015 | 70YY99ANIMAL FEEDS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/21/2014 | 46YV99FOOD ADDITIVES FOR HUMAN USE, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 7/21/2014 | 46YV99FOOD ADDITIVES FOR HUMAN USE, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/3/2010 | 02G08SOYBEAN FLOUR, MEAL, OR POWDER | Los Angeles District Office (LOS-DO) | |
| 11/16/2006 | 45TY99ALL OTHER PRODUCTS, NON-NUTRITIVE SWEETENERS | 238UNSAFE ADD | Seattle District Office (SEA-DO) |
| 6/20/2005 | 54FYY12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 2920PESTICIDES | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Fenchem Biotek Ltd.'s FDA import refusal history?
Fenchem Biotek Ltd. (FEI: 3013257323) has 6 FDA import refusal record(s) in our database, spanning from 6/20/2005 to 5/29/2015.
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. Fenchem Biotek Ltd.'s FEI number is 3013257323.
What types of violations has Fenchem Biotek Ltd. received?
Fenchem Biotek Ltd. has been cited for 7 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 Fenchem Biotek Ltd. come from?
All FDA import refusal data for Fenchem Biotek 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.