Nanjing Chemlin Biomedical Science & Technology Co, Ltd.
⚠️ Moderate Risk
FEI: 3011543781 • Nanjing • CHINA
FEI Number
3011543781
Location
Nanjing
Country
CHINAAddress
NO. 15 Wanshou Road, Pukou District, 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
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
Frequently Asked Questions
What is Nanjing Chemlin Biomedical Science & Technology Co, Ltd.'s FDA import refusal history?
Nanjing Chemlin Biomedical Science & Technology Co, Ltd. (FEI: 3011543781) has 2 FDA import refusal record(s) in our database, spanning from 4/5/2022 to 4/5/2022.
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 Chemlin Biomedical Science & Technology Co, Ltd.'s FEI number is 3011543781.
What types of violations has Nanjing Chemlin Biomedical Science & Technology Co, Ltd. received?
Nanjing Chemlin Biomedical Science & Technology Co, Ltd. 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 Nanjing Chemlin Biomedical Science & Technology Co, Ltd. come from?
All FDA import refusal data for Nanjing Chemlin Biomedical Science & Technology 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.